February 2022 recalls

666 recalls were announced in February 2022.

What the numbers show

Critical: 14
Severe: 241
High: 229
Moderate: 176
Low: 6

Of the 666 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

Which agencies issued them

601–666 of 666

HighFDA (Food)·F-0521-2022·2022-02-02
Inglehoffer Seafood Tartar Sauce Recalled for Undeclared Soy
Beaverton Foods Inc is recalling Inglehoffer Seafood Tartar Sauce with Lemon & Capers because the ingredient label declares soybean oil but does not adequately disclose soy as an allergen, posing a risk to consumers with soy allergies.
Product
Inglehoffer Seafood Tartar Sauce With Lemon & Capers, 8.25oz (234g) jar, UPC 0 71828 01114 1. The label is read in parts: "***Inglehoffer*** Seafood TARTAR SAUCE WITH LEMON & CAPERS*** INGREDIENTS: SOYBEAN OIL, WATER, CUCUMBERS, EGGS, WHITE DISTILLED VINEGAR, SALT, MUSTARD…
Category
Food
Distribution
2 states
HighNHTSA·22V048000·2022-02-02
2021-2022 Keystone RV models recalled for tire belt separation defect
Keystone is recalling 2021-2022 Raptor and 2021 Montana RVs with certain Sailun tires that may experience belt separation. Belt separation could cause loss of vehicle control and increase crash risk.
Product
KEYSTONE — KEYSTONE RAPTOR, MONTANA
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0522-2022·2022-02-02
GAT SPORT JETFUEL DIURETIC dietary supplement recalled for undeclared milk
World Health Products LLC is recalling GAT SPORT JETFUEL DIURETIC capsules because they may contain undeclared milk, a common allergen. The product was distributed across most U.S. states and internationally.
Product
GAT SPORT JETFUEL DIURETIC; FOR RELIEF OF WATER WEIGHT GAIN; Muscle Defining Formula; Stimulant Free Natural Herbal Actives; 90 Oil-Infused Capsules; Dietary Supplement; Other Ingredients: Gelatin (Capsule), Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate…
Category
Food
Distribution
39 states
HighFDA (Drugs)·D-0417-2022·2022-02-02
Phenylephrine HCl Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma is recalling approximately 5,335 syringes of Phenylephrine HCl Sterile Solution for Injection nationwide due to lack of assurance of sterility. The product may not meet sterility requirements for safe use.
Product
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0420-2022·2022-02-02
Edge Pharma Phenylephrine/Tropicamide Ophthalmic Solution Sterility Recall
Edge Pharma is recalling a sterile ophthalmic solution (Phenylephrine HCl/Tropicamide 2.5%/1%) because the manufacturer cannot assure sterility of the product. The recall affects 363 droptainers distributed nationwide.
Product
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V050000·2022-02-02
Tesla Model Y, S, X, and 3 windshield defrosting software defect
Tesla is recalling 2020-2022 Model Y, S, X, and 3 vehicles due to a heat pump software error that reduces windshield defrosting performance. This may decrease driver visibility and increase crash risk.
Product
TESLA — TESLA MODEL S, MODEL Y, MODEL 3, MODEL X
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0619-2022·2022-02-02
Frozen Tuna Steaks Recalled for Elevated Histamine Levels
Relish Foods, Inc. dba Gourmet Fusion Foods is recalling 10 oz. individually wrapped frozen tuna steaks due to elevated histamine levels detected in FDA consumer samples.
Product
10 oz. individually wrapped frozen tuna steaks; 4 servings per bag Important: Thaw under refrigeration immediately before use. May contain bones. Product must be cooked prior to consumption KEEP FROZEN AT -18 CELSIUS OR BELOW THAW UNDER REFRIGERATION IMMEDIATELY BEFORE…
Category
Food
Distribution
1 state
HighFDA (Food)·F-0620-2022·2022-02-02
Bake Crafters Maple Waffle Chicken Sausage Recalled for Listeria Contamination Risk
Bake Crafters is recalling Maple Waffle WG Chicken Sausage due to potential Listeria monocytogenes contamination. The affected products were distributed to distribution centers in Idaho and Pennsylvania.
Product
Bake Crafters - Maple Waffle WG Chicken Sausage Packaged into cardboard containers 126 units per case
Category
Food
Distribution
2 states
HighFDA (Food)·F-0615-2022·2022-02-02
Brownie Points Schmurtle Brownies Recalled for Undeclared Peanut Allergen
Brownie Points LLC is recalling Brownie Points Schmurtle brownies because the label does not disclose peanuts as an allergen. The product was distributed across the United States in gift baskets.
Product
Brownie Points Schmurtle 2oz Packaged in food grade cellophane only used as gift basket filler - not sold individually
Category
Food
Distribution
46 states
HighCPSC·22067·2022-02-02
Games Workshop Recalls KOYO Bounca The Squig Plush Toys for Choking Hazard
Games Workshop is recalling about 2,600 KOYO Bounca The Squig Limited Edition Plush toys because the pom-poms can detach, posing a choking hazard to young children. No injuries have been reported.
Product
KOYO Bounca The Squig Limited Edition Plush toys
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2022·2022-02-02
Methotrexate Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Methotrexate, USP, Sterile Solution for Injection (125 mg/5mL) due to lack of assurance of sterility. The recall affects 457 syringes distributed nationwide.
Product
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0616-2022·2022-02-02
White Cheddar Cheese Recalled for Undeclared Wheat
G&C Food Distributors & Brokers Inc. is recalling white cheddar cheese distributed to Connecticut, New Jersey, New York, Pennsylvania, and Tennessee because the product may contain undeclared wheat, which poses a risk to consumers with wheat allergies.
Product
WHITE CHEDDAR CHEESE; INGREDIENTS: CULTURED PASTEURIZED MILK, SALT, ENZYMES; Distributed By: G&C Foods; ALLERGEN: MILK; CONTAINS: 1 BAG; Product is for Food Service Only; KEEP REFRIGERATED
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0525-2022·2022-02-02
API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect
Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.
Product
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either…
Category
Medical Device
Distribution
4 states
HighCPSC·22068·2022-02-02
Maxtrade Youth ATVs Recalled for Speed and Brake Safety Defects
About 141,000 Maxtrade Coolster Mountopz youth all-terrain vehicles fail to meet federal safety standards. The ATVs exceed maximum speed limits for their intended age groups and some have parking brakes that do not prevent vehicle movement, posing a risk of serious injury or death.
Product
Maxtrade's Youth Coolster Mountopz All-Terrain Vehicles (ATVs)
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2022·2022-02-02
GE Vscan Extend ultrasound device recalled for power-on failure due to battery depletion
GE Healthcare is recalling the Vscan Extend ultrasound device because it will not power on when the battery is depleted. This occurs when the device is not turned off before battery removal or is connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Category
Medical Device
Distribution
50 states
HighFDA (Food)·F-0618-2022·2022-02-02
Sugar Plum Vegetable Seasoning Blend Recalled for Undeclared Wheat
Sugar Plum Inc. is recalling Sugar Plum Vegetable Seasoning Blends Sesame Soy packets due to undeclared wheat allergen. The recall affects 2,892 units distributed to consumers in the US via online sales.
Product
Sugar Plum Vegetable Seasoning Blends Sesame Soy sold in the Veggie Lovers Cooking Kit. 1.5 oz packet. Packaged in a resealable foil bag. UPC:7 4555966500 2
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0423-2022·2022-02-02
Betadine Sterile Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma is recalling Betadine sterile ophthalmic solution syringes due to lack of assurance of sterility. The affected product is a preservative-free, single-use ophthalmic solution distributed nationwide.
Product
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0621-2022·2022-02-02
Sienna Chocolate Decadent Brownie Recalled for Undeclared Pecan
Dianne's Fine Desserts is recalling Sienna Chocolate Decadent Brownie because it contains undeclared pecan, which poses a risk to consumers with pecan allergies.
Product
Sienna Chocolate Decadent Brownie, Net wt. 104 oz. (6-lb. 8 oz.) 2.95 kg., UPC Codes: 8495241115; Product packed in trays covered in clear plastic, trays packed in cardboard case, 4 trays to a case. 1.4 - Unit Size: 6.75 lb tray 1.5 - Container Description: 12 by 16 inch…
Category
Food
Distribution
5 states
HighFDA (Drugs)·D-0403-2022·2022-02-02
Gemcitabine Intravesical Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling approximately 627 syringes of Gemcitabine Sterile Intravesical Solution nationwide because the manufacturer cannot guarantee the product is sterile. The recalled batches were distributed between December 2021 and February 2022.
Product
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0614-2022·2022-02-02
Korean Sushi Recalled for Undeclared Yellow #5 Dye
Han Yang Corp. is recalling Korean Sushi (12 oz., UPC 0 72148 48043 3) distributed in Washington because the product contains undeclared Yellow #5, a food dye that may cause allergic reactions in sensitive consumers.
Product
Korean Sushi, net wt. 12 oz. UPC 0 72148 48043 3. The label is read in parts: "***KOREAN SUSHI ***Ingredients: Rice, Seaweed, Water, Salt, Eggs, Sesame Oil, Spinach, Carrot, Yellow Radish, and Sesame Seed. *** Han Yang Oriental Food Mfg. 3819 94th St. SW, Tacoma, WA 98499…
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0443-2022·2022-02-02
Phenol Topical Solution recalled for CGMP manufacturing deviations
Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0438-2022·2022-02-02
Lidocaine HCl / Oxymetazoline HCl Nasal Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Lidocaine HCl / Oxymetazoline HCl Nasal Solution (4% / 0.05%, 240mL) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0441-2022·2022-02-02
Profound-PE Dental Gel Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 418 jars of the topical oral anesthetic product distributed across multiple lot codes.
Product
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0445-2022·2022-02-02
Vitamin K Oral Solution Recalled for CGMP Deviations
Edge Pharma is recalling 757 syringes of Vitamin K Oral Solution nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall was initiated voluntarily by the firm and has been terminated.
Product
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0518-2022·2022-02-02
GE Vscan Extend ultrasound console fails to power on when battery is depleted
GE Healthcare is recalling the Vscan Extend ultrasound console due to battery depletion that prevents powering on. The problem occurs when the battery depletes if the device is not turned off before battery removal or is connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Console"
Category
Medical Device
Distribution
50 states
ModerateFDA (Drugs)·D-0435-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to CGMP Deviations
Edge Pharma, LLC is recalling 20 vials of Dibutyl Squaric Acid topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The drug was distributed in multiple dose vials containing 1%, 10 mL each.
Product
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0429-2022·2022-02-02
Drug Recall: Cantharidin Gel-Forming Suspension CGMP Deviations
Edge Pharma, LLC is recalling Cantharidin Gel-Forming Suspension 0.7% nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall involves 1173 vials distributed to healthcare facilities.
Product
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0531-2022·2022-02-02
FlexDex 8mm Needle Driver Damaged Packaging Inspection Guidance
FlexDex Inc. is reinforcing instructions for the 8mm FlexDex Needle Driver (Product Code FD-335 ND). Users should not use the product if packaging shows any damage, including pinholes or tears.
Product
8mm FlexDex Needle Driver, Product Code FD-335 ND
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0449-2022·2022-02-02
Trypan Blue Ophthalmic Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Trypan Blue 0.03% ophthalmic solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on December 6, 2021.
Product
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0440-2022·2022-02-02
Profound Dental Gel Recalled for CGMP Manufacturing Deviations
Edge Pharma, LLC is recalling 221 jars of Profound Dental Gel (Lidocaine/Prilocaine/Tetracaine 10%/10%/4%) nationwide due to Good Manufacturing Practice (CGMP) deviations identified during production.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0434-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling 63 vials of Dibutyl Squaric Acid Topical Solution (2%, 10 mL per vial) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0448-2022·2022-02-02
Vancomycin HCl Oral Solution Recalled for CGMP Deviations
Edge Pharma is voluntarily recalling 6,925 syringes of Vancomycin HCl Oral Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process.
Product
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0520-2022·2022-02-02
GE Vscan Extend Ultrasound Device Battery Power Failure Recall
GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Category
Medical Device
Distribution
50 states
ModerateFDA (Drugs)·D-0447-2022·2022-02-02
Tetracaine HCl Nasal Solution Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Tetracaine HCl Nasal Solution, 4%, due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 114 bottles distributed nationwide.
Product
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0444-2022·2022-02-02
Lidocaine HCl/Phenylephrine HCl Nasal Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution (4%/1%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 231 bottles.
Product
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0520-2022·2022-02-02
Beaver Brand Tartar Sauce Recalled for Undeclared Soy
Beaverton Foods Inc is recalling Beaver Brand Tartar Sauce with Fresh Capers and Dill because soybean oil, a soy derivative, is not declared in the ingredients statement. This product may pose a risk to consumers with soy allergies.
Product
Beaver Brand Tartar Sauce with Fresh Capers and Dill, 11.5 oz. (326g) jar. UPC 0 71828 00211 8 The label is read in parts: "***BEAVER*** Tartar SAUCE with fresh capers and dill *** INGREDIENTS: SOYBEAN OIL, WATER, CUCUMBERS, EGGS, WHITE DISTILLED VINEGAR, SALT, MUSTARD SEED…
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-0437-2022·2022-02-02
LET Topical Gel drug recall for CGMP deviations
Edge Pharma is recalling 26,917 syringes of LET Topical Gel nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily in December 2021.
Product
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0521-2022·2022-02-02
GE Vscan Extend Ultrasound Devices May Not Power On Due to Battery Depletion
GE Healthcare is recalling Vscan Extend portable ultrasound devices that may fail to power on due to battery depletion when the device is not turned off before battery removal or before connecting without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
Category
Medical Device
Distribution
50 states
ModerateFDA (Drugs)·D-0431-2022·2022-02-02
FDA Recalls CSF Otic Insufflation Capsule for CGMP Deviations
Edge Pharma, LLC is recalling 1055 bottles of CSF Otic Insufflation Capsule containing Sulfacetamide Sodium, Ciprofloxacin, and Amphotericin B nationwide due to CGMP manufacturing deviations.
Product
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0455-2022·2022-02-02
CTx21 Kit Dental Products Recalled for Subpotent Sodium Fluoride Content
Dental Alliance Holdings LLC is recalling the CTx21 Kit because the product contains less sodium fluoride than stated on the label. Affected lots were distributed nationwide.
Product
CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0433-2022·2022-02-02
Drug Recall: Dexamethasone Sodium Phosphate Topical Solution
Edge Pharma, LLC is recalling Dexamethasone sodium phosphate 0.4% topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in 56 cartons.
Product
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0456-2022·2022-02-02
CariFree CTx26 Kit Recalled for Subpotent Sodium Fluoride Content
Dental Alliance Holdings LLC is recalling the CTx26 Kit because it contains less sodium fluoride than listed on the product label. Affected consumers should contact their dentist or healthcare provider.
Product
CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0400-2022·2022-02-02
Edge Pharma EDTA Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma, LLC is recalling Edetate Disodium (EDTA) 1.5% Sterile Ophthalmic Solution nationwide due to lack of assurance of sterility. The recalled product is a single-dose eye drop solution.
Product
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0459-2022·2022-02-02
CariFree CTx4 Gel 5000 Subpotent Sodium Fluoride Recall
Dental Alliance Holdings LLC is recalling CariFree CTx4 Gel 5000 fluoride gel tubes because they contain less sodium fluoride than stated on the label. The affected product is CTx12 5000 Kit lot 142017.
Product
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0428-2022·2022-02-02
BLT Topical Cream recalled by Edge Pharma for CGMP deviations
Edge Pharma is recalling 1,173 jars of BLT Topical Cream (Benzocaine/Lidocaine/Tetracaine) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, firm-initiated Class II recall.
Product
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0446-2022·2022-02-02
Promethazine HCl Topical Ointment Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Promethazine HCl Topical Ointment, 2.5% due to CGMP (Current Good Manufacturing Practice) deviations. The voluntary nationwide recall affects approximately 7,788 syringes distributed across multiple lots.
Product
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0451-2022·2022-02-02
Metoprolol Succinate ER Tablets Recall for Failed Dissolution
American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets 50 mg nationwide due to failed dissolution specifications. The affected lots may not release the medication properly, potentially reducing its effectiveness.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0454-2022·2022-02-02
CTx7 Kit Recalled for Subpotent Sodium Fluoride Content
The FDA is recalling CTx7 Kits distributed nationwide because the product contains less sodium fluoride than stated on the label.
Product
CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0432-2022·2022-02-02
CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.
Product
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0523-2022·2022-02-02
GE Vscan Extend portable ultrasound may not power on due to battery depletion
GE Healthcare is recalling GE Vscan Extend portable ultrasound devices that may fail to power on if not turned off before battery removal or when connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0522-2022·2022-02-02
GE Vscan Extend Ultrasound System Recalled for Battery Power Failure
GE Healthcare is recalling the Vscan Extend portable ultrasound device due to battery power failure. The device may not power on when the battery is depleted, particularly if not turned off before battery removal or when connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Category
Medical Device
Distribution
50 states
ModerateFDA (Drugs)·D-0430-2022·2022-02-02
Cantharidin PLUS topical suspension recalled for manufacturing deviations
Edge Pharma, LLC is recalling 2,204 vials of Cantharidin PLUS, a topical gel-forming suspension used to treat skin conditions. The recall is due to manufacturing quality control deviations discovered during production.
Product
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0439-2022·2022-02-02
Drug Recall: Profound Dental Gel CGMP Deviations
Edge Pharma is voluntarily recalling 353 jars of Profound Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0452-2022·2022-02-02
Proctofoam Topical Aerosol Recalled for cGMP Manufacturing Deficiencies
Mylan Pharmaceuticals Inc is voluntarily recalling Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol due to current Good Manufacturing Practice (cGMP) deficiencies. The recall affects 233,199 10-gram aerosol containers distributed nationwide.
Product
PROCTOFOAM — PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0409-2022·2022-02-02
Mitomycin-C Ophthalmic Solution Recall Due to Sterility Assurance
Edge Pharma is recalling Mitomycin-C sterile ophthalmic solution syringes because the manufacturer lacks assurance of sterility. The recall affects 154 syringes distributed nationwide.
Product
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0457-2022·2022-02-02
CariFree CTx36 Kit recalled for subpotent fluoride content
Dental Alliance Holdings LLC is recalling the CTx36 Kit because it contains less sodium fluoride than stated on the product label. Affected patients should contact their dentist.
Product
CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0436-2022·2022-02-02
LT Topical Cream Recalled for Manufacturing Practice Deviations
Edge Pharma, LLC is recalling 74 jars of LT Topical Cream (Lidocaine/Tetracaine) nationwide due to deviations from Current Good Manufacturing Practice (CGMP). The firm initiated the voluntary recall on December 6, 2021.
Product
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2022·2022-02-02
Profound-PE Dental Gel Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 175 jars of the topical oral anesthetic gel.
Product
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0519-2022·2022-02-02
GE Vscan Extend Ultrasound Device May Fail to Power On
GE Vscan Extend portable ultrasound devices may not power on due to battery depletion caused by improper device handling. The device must be properly turned off before removing the battery or disconnecting from power sources.
Product
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Category
Medical Device
Distribution
50 states
ModerateFDA (Drugs)·D-0458-2022·2022-02-02
CariFree CTx4 Gel 5000 Sample Boxes Recalled for Subpotent Fluoride
CariFree sample boxes containing CTx4 Gel 5000 are being recalled because the product contains less Sodium Fluoride than stated on the label. Affected lots are 492106 and 492107, distributed nationwide.
Product
CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0393-2022·2022-02-02
Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution
Ascend Laboratories is recalling Metoprolol Succinate Extended-Release Tablets 25 mg nationwide because the tablets failed to meet dissolution specifications, which may affect how the medication releases in the body.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0453-2022·2022-02-02
CariFree CTx4 GEL 5000 Recalled for Subpotent Fluoride Content
CariFree CTx4 GEL 5000 (Lot 142017) contains less sodium fluoride than stated on the label. The product is being recalled and consumers should contact their healthcare provider with questions.
Product
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·22V047000·2022-02-01
Seagrave Recalls 2021 Capitol and Marauder Vehicles for Axle Defect
Seagrave is recalling 2021 Capitol and Marauder vehicles because a rear axle drive pinion may fracture, potentially engaging the parking brake unexpectedly and increasing crash risk.
Product
SEAGRAVE — SEAGRAVE CAPITAL, MARAUDER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V046000·2022-02-01
Jayco Pinnacle and North Point Trailers Recalled for Tire Belt Separation
Jayco is recalling 2021-2022 Pinnacle and North Point trailers with Sailun tires that may experience belt separation, potentially causing loss of vehicle control. Free tire replacement is available through dealers.
Product
JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL PINNACLE, NORTH POINT
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V045000·2022-02-01
Tesla vehicles seatbelt warning chime may fail to activate
Tesla is recalling vehicles with seatbelt warning chimes that may not activate when the driver has not fastened their seat belt. The fix is a free over-the-air software update.
Product
TESLA — TESLA MODEL Y, MODEL 3, MODEL S, MODEL X
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22T002000·2022-02-01
Bridgestone Recalls Firestone Tires Due to Belt Separation Risk
Bridgestone is recalling specific Firestone Transforce tires because an incorrect inner liner compound could cause belt separation, increasing the risk of a crash.
Product
TIRES:TREAD/BELT recall
Category
Vehicle
Distribution
Distributed nationwide

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