The Recall Desk

Archive

March 2022 recalls

662 recalls were announced in March 2022.

What the numbers show

Critical
25
Severe
167
High
312
Moderate
150
Low
8

Of the 662 recalls this month scored against our rubric, 4% are Critical, 25% are Severe.

1–100 of 662

  • SevereNHTSA·22V212000·2022-03-31

    Jayco Recalls 2022 White Hawk Travel Trailers Due to Fire Risk

    Jayco is recalling 2022 White Hawk travel trailers because loose power inlet wiring may cause an electrical arc or short, increasing the risk of a fire.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V210000·2022-03-31

    Chevrolet Traverse roof rail air bag harness connector defect

    General Motors is recalling certain 2020-2022 Chevrolet Traverse and 2021-2022 Buick Enclave vehicles because the harness connector to the roof rail air bags may have incompatible electrical terminals that could prevent air bag deployment in a crash.

    Product
    CHEVROLET — CHEVROLET, BUICK TRAVERSE, ENCLAVE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22E029000·2022-03-31

    GM Recalls Truck Hero Tonneau Covers for Detachment Risk

    General Motors is recalling specific Truck Hero tonneau covers for 2019-2022 Chevrolet and GMC trucks because they may detach while driving, creating a road hazard.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22109·2022-03-31

    Helix Metal Lockable Drug Chests Recalled Due to Locking Mechanism Failure

    Maped Helix USA is recalling about 7,700 Helix Metal Lockable Drug Chests because the locking mechanism can fail, allowing unauthorized access to medications and posing a risk of poisoning.

    Product
    Helix Metal Lockable Drug Chests
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V208000·2022-03-31

    2022 Keystone Alpine Travel Trailers Recalled for Electrical Fire Risk

    Keystone is recalling 2022 Alpine and related travel trailers due to power inlet lug bolts manufactured too hard to tighten properly, causing loose electrical connections that could lead to fire.

    Product
    KEYSTONE — KEYSTONE ALPINE, AVALANCHE, PASSPORT, IMPACT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22110·2022-03-31

    PlayMonster Kid O Hudson Glow Rattles Recalled for Choking Hazard

    PlayMonster is recalling Kid O Hudson Glow Rattles because the rattle's legs can break off, posing a choking hazard to young children. The firm has received three reports of legs breaking off, though no injuries have been reported.

    Product
    Kid O Hudson® Glow Rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22737·2022-03-31

    SOUNDBOKS Gen. 3 Bluetooth Speakers Recalled for Battery Fire Hazard

    SOUNDBOKS Inc. is recalling about 6,700 Gen. 3 Bluetooth speakers because the removable lithium-ion battery can overheat and pose a fire hazard. Consumers should stop using the speakers immediately and contact the company for a free replacement battery.

    Product
    SOUNDBOKS (Gen. 3) Bluetooth Speakers with Lithium-Ion Batteries
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V209000·2022-03-31

    Keystone Cougar travel trailers recalled for outrigger tire clearance defect

    Keystone is recalling 2019-2022 Cougar travel trailers due to improper outrigger clearance that may allow tires to contact the outrigger. Damaged tires can fail and cause loss of vehicle control and increased crash risk.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22111·2022-03-31

    Universal Security Instruments 2-in-1 Smoke and Carbon Monoxide Alarms Recalled for Failure to Alert

    Universal Security Instruments is recalling about 8,000 combination smoke and carbon monoxide alarms that may fail to alert consumers to dangerous carbon monoxide levels. Two units have been reported to fail the alarm function, though no injuries have been reported.

    Product
    2-in-1 Photoelectric Smoke & Fire + Carbon Monoxide Alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V207000·2022-03-31

    2022 Triumph Speed Triple RS Motorcycle Rear Brake Disc Bolts May Loosen

    Triumph is recalling 2022 Speed Triple RS and Speed Triple RR motorcycles because rear brake disc bolts may loosen, potentially preventing the wheel from rotating freely and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH SPEED TRIPLE RS, SPEED TRIPLE RR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0750-2022·2022-03-30

    Fresenius Kabi Sodium Acetate Injection Recalled for Particulate Matter

    Fresenius Kabi USA is recalling sodium acetate injection due to the presence of particulate matter composed of carbon, oxygen, iron, and trace elements in multiple lots distributed nationwide.

    Product
    SODIUM ACETATE — SODIUM ACETATE (SODIUM ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V205000·2022-03-30

    Daimler Recalls 2023 Western Star 4900 Trucks for Brake Line Defect

    Daimler Trucks North America is recalling 2023 Western Star 4900 trucks because incorrectly installed air lines may reduce brake performance, increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0739-2022·2022-03-30

    Hand Sanitizer Isopropyl Alcohol 75% Contaminated with Methanol

    Tennessee Technical Coatings Corporation is recalling one lot of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% (1 U.S. Gallon) due to FDA analysis finding methanol contamination. The product was distributed in Alabama and Tennessee.

    Product
    HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0740-2022·2022-03-30

    Hand Sanitizer Isopropyl Alcohol Recall Due to Methanol Contamination

    Tennessee Technical Coatings is recalling hand sanitizer products due to CGMP deviations. Certain lots were manufactured under the same conditions as a product lot found to contain methanol.

    Product
    HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0724-2022·2022-03-30

    Sincalide Injection Recalled for Potency and Reconstitution Issues

    Olympia Compounding Pharmacy is recalling Sincalide lyophilized powder for injection due to concerns about super potency and failed reconstitution time. The product is distributed nationwide, including Puerto Rico.

    Product
    Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compou
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0907-2022·2022-03-30

    Sprouts Dark Chocolate Covered Cherries Recalled for Undeclared Tree Nuts

    Sprouts Farmers Market Dark Chocolate Covered Cherries may contain undeclared almonds. The FDA issued a Class I recall for this undeclared tree nut allergen.

    Product
    Sprouts Farmers Market Dark Chocolate Covered Cherries; Dried Cherries covered in Rich Dark Chocolate. Net Wt. 12 oz (340g) Item # 638-011 UPC: 6 46670 46342 6 Processed in a facility that processes on shared equipment with peanuts, tree nuts, wheat and milk. Distribu
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0668-2022·2022-03-30

    Blaine Labs Revitaderm Wound Care Gel Recalled for Bacillus Contamination

    The FDA has recalled Revitaderm Wound Care gel (Benzalkonium Chloride 0.1%) distributed nationwide due to contamination with Bacillus cereus. The affected product was distributed to 45 doctors in 17 states.

    Product
    REVITADERM WOUND CARE — REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0785-2022·2022-03-30

    Philips Respironics respiratory ventilators recalled for foam degradation

    Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.

    Product
    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0900-2022·2022-03-30

    Shredded Cheese Recalled for Potential Metal Contamination

    Schreiber Foods is recalling shredded cheese due to potential metal contamination. No illnesses have been reported.

    Product
    Shredded Cheese consisting of Monterey Jack, Queso Quesadilla, and Asadero cheeses, Net Wt 2lbs, packaged in plastic pouches, 12 pouches per case.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0813-2022·2022-03-30

    Outset Tablo Hemodialysis Console Recalled for Heat Damage Risk

    Outset Medical is recalling Tablo hemodialysis consoles (models PN-0003000 and PN-0006000) nationwide due to a component that may cause heat-related damage to the device.

    Product
    Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2022·2022-03-30

    Azurion Medical Imaging System Software Defect Affects Patient Dose Control

    Philips Azurion R2.1 systems have a software defect that causes the Patient Type to change unexpectedly when starting a procedure, potentially affecting dose control settings without user notification.

    Product
    Azurion systems with software release R2.0.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2022·2022-03-30

    Biomet Surgical Implant Reamer Recall: Packaging Sterile Barrier Risk

    Biomet is recalling surgical implant reamers due to packaging that may lose sterile barrier integrity, risking post-surgical infection.

    Product
    BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0819-2022·2022-03-30

    Infusion Pump Risk of Malfunction in B. Braun Perfusor Space Devices

    B. Braun is recalling 6 Perfusor Space infusion pump units that may not function properly due to inadequate inspection, potentially causing incorrect medication dosing and therapy delays.

    Product
    PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0683-2022·2022-03-30

    Fluocinonide Cream Recalled for Manufacturing Compliance and Stability Deviations

    Teligent Pharma, Inc. is recalling Fluocinonide Cream USP 0.1% due to manufacturing compliance deviations and discontinuation of stability studies. The recall affects products nationwide in the USA and Puerto Rico.

    Product
    Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2022·2022-03-30

    NuOss Collagen Blocks Recalled Due to Product Substitution Error

    Ace Surgical Supply is recalling NuOss Collagen Blocks because some units were mistakenly packaged with Collatene Fibrillar Collagen instead, which may result in suboptimal bone repair during dental and maxillofacial procedures.

    Product
    NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0901-2022·2022-03-30

    Overnight Oats Recall: Undeclared Almond and Coconut Allergens

    HumbleHungryHappy LLC is recalling Overnight Oats due to undeclared almond and coconut allergens on the label. Consumers with allergies to these ingredients face potential health risks.

    Product
    Overnight Oats, net wt. 9.4 oz. It is packaged in flexible plastic bowl with film lid. Product label is read in parts: "***OVERNIGHT OATS***Ingredients: 1% Greek Yogurt ***Coconut Milk, Orgain Organic Protein, Rolled Oats, Almond, Milk, Honey, Flaxseeds, Coconut***Contains: Mi
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0908-2022·2022-03-30

    Snak Yard Dried Plums Recalled for Potential High Lead Content

    Alli & Rose LLC is recalling Snak Yard Dried Plums Saladitos due to potential high lead content. Affected products were distributed in California with best-before dates of February 14, 2023, or April 29, 2023.

    Product
    Snak Yard Dried Plums Saladitos; 12.7 oz. net wt (360g) Item number 1546905 UPC: 8 10019 60082 1 Made in China; Packed in Thailand Distributed by Alli & Rose LLC, 1422 E, ?M?ain St. PMB #210 Lincolnton NC 28092
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0817-2022·2022-03-30

    Codman Cranial Access Kits Recalled Due to Incorrect Expiration Dates on Labels

    Integra LifeSciences is recalling 1,161 Codman Cranial Access Kits due to incorrect expiration dates on the outer box labels. Using the product past its correct expiration date may cause pain, infection, or adverse tissue reaction.

    Product
    Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0681-2022·2022-03-30

    Diflorasone Diacetate Ointment recalled due to discontinued stability studies

    Teligent Pharma is recalling all unexpired Diflorasone Diacetate Ointment 0.05% due to cGMP deviations. The company discontinued its stability study program, preventing verification that the product maintains safety and effectiveness throughout shelf life.

    Product
    Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0902-2022·2022-03-30

    PB Choc Protein Bites Recalled for Undeclared Coconut Allergen

    HumbleHungryHappy LLC is recalling PB Choc Protein Bites because coconut is not listed in the allergen declaration, posing a risk to consumers with coconut allergies.

    Product
    PB CHOC PROTEIN BITES, net wt. 7.2 oz. There are 6 bites in a rectangular flexible plastic clamshell covered with plastic film lid. Product label is read in parts: "***PB CHOC PROTEIN BITE***Ingredients: Peanut Butter, Coconut Milk, Orgain Organic Protein, Hershey Semi-Sweet
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0810-2022·2022-03-30

    BIOMET Trauma DVR CROSSLOCK implants recalled for packaging integrity

    BIOMET Trauma DVR CROSSLOCK surgical implant plates may have packaging that does not maintain sterile barrier integrity, posing a risk of infection.

    Product
    BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Drugs)·D-0669-2022·2022-03-30

    FDA Recalls Betamethasone Dipropionate Lotion Due to Manufacturing Deviations

    Teligent Pharma is recalling Betamethasone Dipropionate Lotion due to manufacturing practice deviations and discontinuation of the stability study program. The recall affects 43,218 bottles distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0706-2022·2022-03-30

    Norepinephrine Bitartrate Injection Recalled Due to Defective Container

    Athenex Pharma Solutions is recalling Norepinephrine Bitartrate Injection due to defective containers affecting specific lots distributed nationwide.

    Product
    Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0719-2022·2022-03-30

    FDA Recalls NAD+ Injection Due to Sub-Potency and Stability Concerns

    Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide injection vials nationwide due to sub-potency or exceeded reconstitution time.

    Product
    NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceutica
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2022·2022-03-30

    Codman Cranial Access Kits Recall: Incorrect Expiration Dates on Labels

    Integra LifeSciences is recalling Codman Cranial Access Kits due to incorrect extended expiration dates printed on outer box labels. Using expired kits may result in pain, infection, or adverse tissue reaction.

    Product
    Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0717-2022·2022-03-30

    Eye Lubricant Drops Recalled for Insufficient Sterility Assurance

    Akorn, Inc. is recalling 62,331 boxes of TheraTears Extra lubricant eye drops distributed nationwide due to lack of assured sterility. Non-sterile eye drops could pose infection risks.

    Product
    THERATEARS EXTRA — THERATEARS EXTRA (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2022·2022-03-30

    Biomet Fibula Composite Locking Plate Recall Due to Sterile Barrier Packaging Defect

    Biomet is recalling TRAUMA A.L.P.S. fibula composite locking plates due to packaging that may not maintain sterile barrier integrity, posing a risk of infection if used.

    Product
    BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0821-2022·2022-03-30

    Medical Device Air Supply Unit Recalled for Potential Electrical Shock Hazard

    Baxter Healthcare is recalling the Compella Therapy Air Supply Unit due to potential power cord damage that could expose electrical conductors and create a shock risk. The recall affects 6,022 units distributed worldwide.

    Product
    Compella Therapy Air Supply Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2022·2022-03-30

    Compella Bariatric Bed System Recall—Power Cord Electrical Shock Risk

    Baxter Healthcare is recalling the Compella Bariatric Bed System due to potential power cord damage that could expose electrical conductors, creating a shock hazard. Approximately 5186 units worldwide are affected.

    Product
    Compella Bariatric Bed System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0897-2022·2022-03-30

    Flow Alkaline Spring Water Recalled Due to Alleged Adverse Reactions

    Flow Beverages Inc. is recalling Flow Alkaline Spring Water (Organic lemon & ginger, 500 ml) due to four customer complaints of alleged adverse reactions. Affected lots are 2023AUG29 V5, distributed to eleven states.

    Product
    Flow Alkaline Spring Water - Organic lemon & ginger flavored water. 500 ml unit . Tetra Pak paper carton.
    Category
    Food
    Distribution
    11 states
  • HighNHTSA·22V206000·2022-03-30

    2022 Keystone Passport Travel Trailers Recalled for Incorrect Axles and Tires

    Keystone RV Company is recalling 2022 Passport travel trailers equipped with incorrect size axles and tires that could cause overloading. Dealers will replace the suspension components free of charge.

    Product
    KEYSTONE — KEYSTONE PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2022·2022-03-30

    Biomet Trauma Surgical Instruments Recalled Due to Packaging Defect

    Biomet is recalling TRAUMA Drill Bits, Taps, and Guide Pins due to packaging that may not seal properly, potentially compromising sterile barrier integrity and posing a risk of surgical site infection.

    Product
    BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill B
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Food)·F-0906-2022·2022-03-30

    Thai Noodle Salad Kits recalled for potential foreign material contamination

    Pacific Coast Fruit Company is recalling Kit Thai Noodle Salad FM due to potential foreign material in an ingredient. The product was distributed to retailers in Alaska, Idaho, Oregon, and Washington.

    Product
    Kit Thai Noodle Salad FM; Net weight 6.75 lbs. UPC 0-20728-72698-0. Product is RTE, refrigerated, ready to mix by the retailer for sale at the retail store. Product comes in a kit that contains Thai Noodle Salad Base (recalled by Fresh Creative Foods; RES 89741), brussels/carrot
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0899-2022·2022-03-30

    Damascus Bakery Bantam Classic Bagels Recalled for Undeclared Egg Allergen

    Damascus Bakery is recalling Bantam Classic Bagels due to undeclared egg allergen. Affected product was distributed to SC, PA, MA, MN, NY, and IN.

    Product
    Damascus Bakery, Bantam Classic Bagels, 6/1.3 oz pieces per carton (7.8 oz), Paper Carton .
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0688-2022·2022-03-30

    Halobetasol Propionate Ointment Recalled for cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Halobetasol Propionate Ointment 0.05% nationwide due to cGMP deviations. The manufacturer is discontinuing its stability study program.

    Product
    Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0707-2022·2022-03-30

    Norepinephrine Bitartrate Injection Recalled for Defective Container

    Athenex Pharma Solutions recalls Norepinephrine Bitartrate Injection due to defective container issues. The recall affects 5,320 bags distributed nationwide.

    Product
    Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0687-2022·2022-03-30

    Gentamicin Sulfate Ointment Recalled Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Gentamicin Sulfate Ointment USP 0.1% due to cGMP deviations related to discontinuation of the firm's stability study program.

    Product
    Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0694-2022·2022-03-30

    Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations

    Teligent Pharma, Inc. is recalling all unexpired batches of Lidocaine Ointment USP, 5% nationwide and in Puerto Rico because the manufacturer is discontinuing its stability study program, a violation of good manufacturing practices.

    Product
    Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0708-2022·2022-03-30

    Norepinephrine Bitartrate Injection Recalled for Defective Container

    Athenex Pharma Solutions is recalling Norepinephrine Bitartrate Injection 8 mg per 250 mL due to a defective container. The recall affects approximately 9,800 bags distributed nationwide.

    Product
    Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0822-2022·2022-03-30

    Medical device products from Family Dollar stores recalled for rodent contamination risk

    Medical device products from Family Dollar stores in six Southern states are being recalled due to potential rodent activity at a distribution center. Affected items include feminine hygiene products, surgical masks, contact lens solutions, and bandages.

    Product
    Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. The general categories of products, but are limited to these products, includes: feminine hygiene products, surgical masks, contact le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2022·2022-03-30

    Cytocell Microscope Slides Recall: Incorrect Expiry Date on Label

    Cytocell Ltd. is recalling Cytocell 8 Square Template Slides because the outer label displays an incorrect expiration date of 2023-05 when the actual validated shelf life expires 2022-02.

    Product
    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0675-2022·2022-03-30

    Desonide Ointment Recalled Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Desonide Ointment 0.05% nationwide because the manufacturer is discontinuing its stability study program, a deviation from current good manufacturing practices (cGMP).

    Product
    Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0685-2022·2022-03-30

    Fluocinonide Topical Solution Recalled Due to Manufacturing Deviations

    Teligent Pharma recalled Fluocinonide Topical Solution USP 0.05% nationwide because the manufacturer is discontinuing stability testing. Without ongoing verification, the company cannot ensure product safety.

    Product
    Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0825-2022·2022-03-30

    DigniCap Delta Scalp Cooling System instructions updated for headband use

    Dignitana updated instructions for the DigniCap Delta Scalp Cooling System to recommend headband use and warn about condensation risk in certain environmental conditions.

    Product
    DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN,
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-0684-2022·2022-03-30

    Fluocinonide Gel Recalled for Manufacturing Process Deviations

    Teligent Pharma, Inc. is recalling all Fluocinonide Gel USP 0.05% nationwide within expiration date due to manufacturing deviations related to discontinued stability studies.

    Product
    Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0814-2022·2022-03-30

    TCL1 Breakapart Probe May Display Unexpected Genetic Signals

    Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.

    Product
    TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0672-2022·2022-03-30

    Clobetasol Propionate Lotion recall due to manufacturing deviations

    Teligent Pharma is recalling 35,180 bottles of Clobetasol Propionate Lotion 0.05% nationwide due to manufacturing deviations and discontinued stability testing. No illnesses reported.

    Product
    Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0712-2022·2022-03-30

    Epinephrine Injection recalled due to defective container

    Athenex Pharma Solutions is recalling Epinephrine Injection 8 mg per 250 mL (excel bag) nationwide due to a defective container. The affected lots are F2101780 and F2101781, expiring 6/21/22.

    Product
    Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0697-2022·2022-03-30

    Triamcinolone Acetonide Cream USP 0.1% Recall — Stability Study Discontinuation

    Teligent Pharma is recalling all unexpired Triamcinolone Acetonide Cream USP 0.1% nationwide due to discontinuation of its stability study program, which creates a cGMP deviation. The company has recalled approximately 721,225 tubes and 90,893 jars distributed across multiple package sizes.

    Product
    Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0673-2022·2022-03-30

    Clobetasol Propionate Ointment USP 0.05% Nationwide Recall

    Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Ointment USP 0.05% nationwide because the manufacturer is discontinuing its stability study program, raising questions about product integrity.

    Product
    Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0682-2022·2022-03-30

    Econazole Nitrate Cream Recalled Due to Manufacturing Process Deviations

    Teligent Pharma is recalling Econazole Nitrate Cream, 1% due to current Good Manufacturing Practice deviations related to discontinued stability studies. Approximately 151,975 tubes distributed nationwide are affected.

    Product
    Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0674-2022·2022-03-30

    Clobetasol Propionate Gel Recalled Due to Manufacturing Deviations

    Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Gel 0.05% due to deviations from good manufacturing practices. The firm discontinued its stability study program, prompting the recall of 81,883 tubes distributed nationwide and in Puerto Rico.

    Product
    Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0700-2022·2022-03-30

    Clobetasol Propionate Cream USP Recalled for cGMP Deviations

    Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP 0.05% in 60-gram tubes due to current Good Manufacturing Practice (cGMP) deviations. The firm discontinued its stability study program, affecting all products within expiry nationwide and in Puerto Rico.

    Product
    Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0722-2022·2022-03-30

    FDA recalls SB-4 compounded injection nationwide for below-strength potency

    SB-4 compounded injection is being recalled nationwide because it contains less active ingredient than labeled. Olympia Compounding Pharmacy initiated this voluntary recall affecting 1,032 vials.

    Product
    SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Man
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0690-2022·2022-03-30

    Hydrocortisone Butyrate Lotion recalled due to cGMP deviations

    Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% (4 fl. oz. bottles) nationwide because the manufacturer discontinued its stability study program, which is a deviation from good manufacturing practice standards.

    Product
    Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0678-2022·2022-03-30

    Desoximetasone Ointment USP Recalled by Teligent Pharma

    Teligent Pharma is recalling Desoximetasone Ointment USP 0.25% in all sizes nationwide due to cGMP deviations related to discontinuation of the stability study program.

    Product
    Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0720-2022·2022-03-30

    Compounded injectable Formula F9 recalled for insufficient potency

    Olympia Compounding Pharmacy recalled Formula F9, a compounded injectable medication, because the product was sub-potent with insufficient active ingredient. The recall affected 493 vials distributed nationwide.

    Product
    Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alco
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0721-2022·2022-03-30

    Olympia Compounding Pharmacy recalls T-105 drug injection for potency issue

    Olympia Compounding Pharmacy is recalling T-105, a compounded injectable drug containing papaverine, phentolamine, and PGE, due to a potency issue. The recall affects 1,093 vials distributed nationwide including Puerto Rico.

    Product
    T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sod
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0701-2022·2022-03-30

    Diflorasone Diacetate Ointment USP 0.05% Nationwide Recall

    Teligent Pharma is recalling all unexpired batches of Diflorasone Diacetate Ointment USP 0.05% nationwide due to cGMP deviations related to discontinuation of the stability study program.

    Product
    Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0676-2022·2022-03-30

    Desoximetasone Ointment USP 0.05% Recalled Due to cGMP Deviations

    Teligent Pharma is recalling Desoximetasone Ointment USP 0.05% nationwide due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program, affecting all products within expiry.

    Product
    Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0677-2022·2022-03-30

    Desoximetasone Ointment USP 0.05% Recall Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Desoximetasone Ointment USP 0.05% (54,897 tubes) distributed nationwide because the manufacturer is discontinuing its stability study program, a violation of current good manufacturing practices.

    Product
    Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0691-2022·2022-03-30

    Halobetasol Propionate Ointment recalled due to cGMP deviations

    Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% (21,323 tubes) due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program.

    Product
    Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0698-2022·2022-03-30

    Triamcinolone Acetonide Lotion Recalled for cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Triamcinolone Acetonide Lotion USP 0.025% due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0714-2022·2022-03-30

    Diclofenac Sodium Topical Solution recalled due to leaking containers

    Direct Rx is recalling Diclofenac Sodium Topical Solution 1.5% (150 mL) nationwide due to defective containers that may leak. Consumers who have purchased this product should stop use and contact their pharmacy or physician.

    Product
    Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0704-2022·2022-03-30

    Lidocaine Cream 4% Recalled Due to Manufacturing Quality Deviations

    Teligent Pharma is recalling all unexpired batches of Lidocaine Cream 4% (30-gram tubes) nationwide because the company is discontinuing its stability study program, a violation of manufacturing standards.

    Product
    Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0692-2022·2022-03-30

    Hydrocortisone Butyrate Lotion Recalled Due to cGMP Deviations

    Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% nationwide due to cGMP deviations. The firm discontinued its stability study program, prompting recall of all products within expiry.

    Product
    Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0689-2022·2022-03-30

    Halobetasol Propionate Ointment Recalled for cGMP Deviations

    Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% due to current Good Manufacturing Practice (cGMP) deviations. The firm has discontinued its stability study program.

    Product
    Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0693-2022·2022-03-30

    Lidocaine Cream 4% Recalled Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired Lidocaine Cream 4% due to manufacturing quality deviations. The firm has discontinued its stability study program.

    Product
    Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jer
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0695-2022·2022-03-30

    Nystatin and Triamcinolone Acetonide Ointment Recall Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Nystatin and Triamcinolone Acetonide Ointment (15g, 30g, and 60g tubes) nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.

    Product
    Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0715-2022·2022-03-30

    Rock Town Distillery Hand Sanitizer Recall Due to Chemical Contamination

    Rock Town Distillery is recalling hand sanitizer products distributed in Arkansas due to FDA findings of acetal and acetaldehyde above specification limits resulting from manufacturing deviations.

    Product
    ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery,
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0686-2022·2022-03-30

    Gentamicin Sulfate Cream USP 0.1% Recalled for cGMP Deviations

    Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% distributed nationwide because the manufacturer is discontinuing its stability study program, which represents a deviation from FDA good manufacturing practices (cGMP).

    Product
    Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0670-2022·2022-03-30

    Clobetasol Propionate Cream Recalled Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Cream USP 0.05% nationwide because the manufacturer is discontinuing its stability study program and cannot ensure compliance with current Good Manufacturing Practice standards.

    Product
    Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0718-2022·2022-03-30

    Sermorelin Acetate Injectable Recalled for Sub-Potent Strength

    Olympia Compounding Pharmacy is recalling Sermorelin Acetate 9 mg multi-dose vials nationwide due to sub-potency. The affected lots do not contain the full intended strength of the medication.

    Product
    Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0705-2022·2022-03-30

    Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations

    Teligent Pharma, Inc. is recalling Lidocaine Ointment USP 5% nationwide because the manufacturer is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practice (cGMP). All products within their expiration dates are affected.

    Product
    Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0709-2022·2022-03-30

    Phenylephrine HCl Injection Recalled Due to Defective Container

    Athenex Pharma Solutions is recalling one lot of Phenylephrine HCl Injection due to a defective container. The recall affects 670 bags distributed nationwide.

    Product
    Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0679-2022·2022-03-30

    Diclofenac Sodium Topical Solution recalled by Teligent Pharma

    Teligent Pharma is recalling all unexpired batches of Diclofenac Sodium Topical Solution 1.5% due to current good manufacturing practice (cGMP) deviations related to discontinuation of the firm's stability study program.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0680-2022·2022-03-30

    Diclofenac Sodium Topical Solution Recalled for Manufacturing Compliance Deviations

    Teligent Pharma recalled 36,018 bottles of Diclofenac Sodium Topical Solution nationwide due to cGMP deviations related to discontinued stability studies, affecting all batches through May 2024.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0710-2022·2022-03-30

    Phenylephrine HCl Injection 50 mg Recalled for Defective Container

    Athenex Pharma Solutions is voluntarily recalling Phenylephrine HCl Injection 50 mg in 250 mL excel bags distributed nationwide due to a defective container issue. The recall affects approximately 1,800 bags across three lots.

    Product
    Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0904-2022·2022-03-30

    Bison Shepherd's Pie recalled for incomplete fish allergen labeling

    HumbleHungryHappy LLC recalls Bison Shepherd's Pie (10.5 oz and 15 oz) distributed in Oregon and online due to incomplete fish allergen declaration. The label declares 'Fish' but does not specify the fish type.

    Product
    Bison Shepherd's Pie, packaged meal, net wt. 10.5oz and 15 oz. Product is fully cooked, refrigerated, and to-be-reheated by consumers for immediate consumption. Product is packaged in a rectangular flexible plastic clamshell covered with plastic film lid. Product label is rea
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0696-2022·2022-03-30

    Triamcinolone Acetonide Ointment USP 0.5% Recalled by Teligent Pharma

    Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.5% due to current good manufacturing practice (cGMP) deviations. The firm has discontinued its stability study program, affecting approximately 159,994 tubes distributed nationwide.

    Product
    Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0702-2022·2022-03-30

    Gentamicin Sulfate Cream Recalled Due to Manufacturing Practice Violations

    Teligent Pharma, Inc. is recalling 31,489 tubes of Gentamicin Sulfate Cream (0.1%) nationwide due to manufacturing violations. The company discontinued its stability testing program without proper authorization.

    Product
    Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0711-2022·2022-03-30

    Phenylephrine HCl Injection Recalled for Defective Container

    Athenex Pharma Solutions is recalling Phenylephrine HCl Injection (20 mg, 250 mL excel bags) distributed nationwide due to defective container issues. The recall affects three specific lots.

    Product
    Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0896-2022·2022-03-30

    Flow Alkaline Spring Water Organic Lemon Ginger Recalled for Adverse Reactions

    Flow Beverages Inc. is recalling Flow Alkaline Spring Water in organic lemon and ginger flavor due to four customer complaints of alleged adverse reactions. The affected product was distributed across multiple U.S. states.

    Product
    Flow Alkaline Spring Water - Organic lemon & ginger flavored water. 500 ml 12 units per case . Tetra Pak paper carton.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0703-2022·2022-03-30

    Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations

    Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program.

    Product
    Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0671-2022·2022-03-30

    Clobetasol Propionate Cream USP 0.05% Recall for cGMP Deviations

    Teligent Pharma is recalling all unexpired Clobetasol Propionate Cream USP 0.05% nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the firm's stability study program.

    Product
    Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2022·2022-03-30

    Triamcinolone Acetonide Ointment Recalled Due to cGMP Deviations

    Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% nationwide because the manufacturer is discontinuing its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation.

    Product
    Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0905-2022·2022-03-30

    Marine Corps Mash packaged meal recall for incomplete fish allergen labeling

    HumbleHungryHappy LLC is recalling Marine Corps Mash packaged meals (9.8 oz and 13.8 oz) distributed in Oregon and online because the product declares fish as an allergen but does not specify the type of fish.

    Product
    Marine Corps Mash, packaged meal, net wt. 9.8 oz and 13.8 oz. Product is fully cooked, refrigerated, and to-be-reheated by consumers for immediate consumption. Product is packaged in a rectangular flexible plastic clamshell covered with plastic film lid. Product label is rea
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-0903-2022·2022-03-30

    Bison Breakfast Meal Recalled for Unspecified Fish Allergen

    HumbleHungryHappy LLC recalls 97 containers of Bison Breakfast due to incomplete allergen labeling: the product declares Fish but does not specify which fish. Consumers with fish allergies may not have adequate warning.

    Product
    Bison Breakfast, packaged meal, net wt. 11.5oz. Product is fully cooked, refrigerated, and to-be-reheated by consumers for immediate consumption. Product is packaged in a rectangular flexible plastic clamshell covered with plastic film lid. Product label is read in parts: "**
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0723-2022·2022-03-30

    Hydroxocobalamin B12 Injection Recalled for Sub-Potent Dose

    Olympia Compounding Pharmacy is recalling Hydroxocobalamin B12 1mg/mL injection vials distributed nationwide because the product is sub-potent (below specified strength). The firm initiated this voluntary recall on March 8, 2022.

    Product
    Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30
    Category
    Drug
    Distribution
    Distributed nationwide

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