The Recall Desk

Archive

August 2022 recalls

577 recalls were announced in August 2022.

What the numbers show

Critical
6
Severe
89
High
324
Moderate
155
Low
3

Of the 577 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

301–400 of 577

  • HighFDA (Devices)·Z-1552-2022·2022-08-24

    FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.

    Product
    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2022·2022-08-24

    SKYN Non-Latex Condoms Recalled Due to Improper Storage

    Family Dollar is recalling SKYN Original, Elite, and LS non-latex condoms due to improper storage. Products sold between May 1 and June 10, 2022 were not stored in temperature-controlled conditions.

    Product
    SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2022·2022-08-24

    Skin liquid bandage recalled for improper temperature storage

    Family Dollar's NEW SKIN Liquid Bandage was not stored in temperature-controlled conditions, potentially compromising product integrity. Affected units were sold nationwide during May through June 2022.

    Product
    NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1553-2022·2022-08-24

    Kabobs Truffle Arancini Recalled for Potential Glass Contamination

    Kabobs Acquisition Inc. is recalling Truffle Arancini with Wild Mushrooms due to potential glass pieces in the rice. The product was distributed to multiple states.

    Product
    Kabobs The Hors d'oeuvre Specialist TRUFFLE ARANCINI WITH WILD MUSHROOMS 180 COUNT Prepared by: Kabobs, Inc., 5423 North Lake Dr., Lake City, GA 30260
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1561-2022·2022-08-24

    Buckwheat Flour Recalled Due to Plastic Contamination

    Minn Dak Growers recalls Fancy Buckwheat Flour due to plastic foreign material contamination. Two lot numbers were distributed in Indiana; affected consumers should discard the product.

    Product
    Fancy Buckwheat Flour, Item #327, 50 lbs. net wt, Packed by Min-Dak Growers Grand Forks, ND - Product of the USA. Manufactured for Enjoy Life Foods.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1559-2022·2022-08-24

    Blue Diamond Growers recalls whole brown almonds for Salmonella risk

    Blue Diamond Growers is recalling whole brown almonds due to potential Salmonella contamination. Although none of the recalled products tested positive, the company is conducting a precautionary recall.

    Product
    Whole Brown Almonds (bulk)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1552-2022·2022-08-24

    Kabobs Arancini Recalled for Possible Glass Contamination

    Kabobs Acquisition Inc. is recalling Tomato, Basil & Mascarpone Arancini products due to possible glass contamination from their rice supplier. Affected lot numbers include PM22F23, PM22F30, and PM22G13.

    Product
    Kabobs The Hors d'oeuvre Specialist TOMATO, BASIL & MASCARPONE ARANCINI 180 COUNT Prepared by: Kabobs, Inc., 5423 North Lake Dr., Lake City, GA 30260
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1545-2022·2022-08-24

    Factor Vegan Mushroom Marsala recalled for glass contamination in rice ingredient

    FACTOR is recalling Factor Vegan Mushroom Marsala 12.7oz meals due to glass contamination in the arborio rice ingredient. The recall affects 48,962 units with best-by dates in June and July 2022.

    Product
    Factor Vegan Mushroom Marsala with onion risotto & roasted garlic green beans 12.7oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1549-2022·2022-08-24

    Factor Ready-to-Eat Meals Recalled Due to Glass in Arborio Rice

    Factor is recalling 10,545 units of Summertime Filet & Sweet Corn Risotto meals (best-by 07/20/2022) because the arborio rice ingredient contains glass fragments.

    Product
    Factor Summertime Filet & Sweet Corn Risotto with Sweet Peach-Berry Crumble & Zucchini Medley 15.2oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1544-2022·2022-08-24

    HEB Ice Cream Recalled for Undeclared Wheat Allergen

    HEB Creamy Creations Light Mint Chocolate Chip ice cream (880 cups) is recalled due to undeclared wheat. Consumers with wheat allergies are at risk.

    Product
    HEB Creamy Creations Light 1/1 The Fat 1/3 Fewer Calories Of Regular Ice Cream Mint Chocolate Chip Ice Cream Half Gallon (1.89L) UPC 4122048399 packaged in a paper carton with a paper lid with a plastic edge
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1548-2022·2022-08-24

    Factor Tomato & Roasted Vegetable Risotto Recalled for Glass in Rice

    Factor is recalling Tomato & Roasted Vegetable Risotto (12.6 oz) because the arborio rice ingredient contains glass. The recall affects 23,439 units.

    Product
    Factor Tomato & Roasted Vegetable Risotto with toasted pine nuts 12.6oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1560-2022·2022-08-24

    Sweet Loren's Place and Bake Sugar Cookie Dough Recalled for Undeclared Gluten

    Sweet Loren's Place and Bake Sugar Cookie Dough labeled as gluten-free has been recalled because it actually contains gluten. This poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Sweet Loren's Place and Bake Sugar Cookie Dough, Net Wt. 12 oz.
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Drugs)·D-1335-2022·2022-08-24

    Drug Recall: Incorrect Syringe in ZYNRELEF Anesthetic Delivery Kits

    Heron Therapeutics is recalling 1,790 kits of ZYNRELEF (bupivacaine and meloxicam) distributed nationwide because one lot contains an incorrect syringe in the delivery system. No illnesses or injuries have been reported.

    Product
    ZYNRELEF — ZYNRELEF (BUPIVACAINE AND MELOXICAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1353-2022·2022-08-24

    Akorn Pharma recalls Acetaminophen 500 mg tablets with missing imprints

    Akorn Pharma, Inc. is recalling Acetaminophen 500 mg Extra Strength tablets because the imprint identification marking is missing from the tablets. The recall affects 30,325 bottles distributed to wholesalers.

    Product
    Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1536-2022·2022-08-24

    CURAD Waterproof Bandages Recalled for Improper Storage

    Family Dollar is recalling CURAD waterproof bandages due to improper storage outside temperature-controlled conditions. The recall affects approximately 419 units sold nationwide between May 1 and June 10, 2022.

    Product
    CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1343-2022·2022-08-24

    Rifampin Capsules Recalled Due to Manufacturing Control Deviation

    Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2022·2022-08-24

    Contact Lens Solution Recalled for Improper Temperature Storage

    OPTI FREE REPLENISH contact lens solution sold at Family Dollar stores (May 1–June 10, 2022) was not stored in temperature-controlled areas and is being recalled.

    Product
    OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1544-2022·2022-08-24

    Polident Denture Cleansers Recalled Due to Improper Storage

    Polident denture cleansers sold at Family Dollar stores nationwide are being recalled due to improper storage conditions. No illnesses or injuries have been reported.

    Product
    POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1534-2022·2022-08-24

    Denture Cleanser Tablets Recalled for Improper Storage Conditions

    Family Dollar is recalling GS Denture Cleanser tablets (green and overnight formulas) due to improper storage in non-temperature-controlled areas. Products sold May 1 - June 10, 2022 may be affected.

    Product
    GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1358-2022·2022-08-24

    Hand Sanitizer Recalled for Manufacturing Process Deficiency

    Protect U Guard Foaming Hand Sanitizer is being recalled due to a manufacturing deficiency in the deionized water system. The product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1352-2022·2022-08-24

    Acetaminophen 325 mg tablets recalled for missing imprint

    Akorn Pharma is recalling 301,382 bottles of Acetaminophen 325 mg tablets because the tablets lack the required "AP 325" imprint marking.

    Product
    Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1349-2022·2022-08-24

    Azacitidine for Injection Recalled Nationwide for Subpotent Dosage

    Amerisource Health Services is recalling 4,160 vials of Azacitidine for Injection nationwide due to subpotency. The affected vials may contain less than the labeled 100 mg of active ingredient.

    Product
    Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2022·2022-08-24

    At-home marijuana test strips recalled for improper storage

    Family Dollar is recalling at-home marijuana test strips (SKU 900752) that were stored outside temperature-controlled areas. Improper storage may affect test accuracy.

    Product
    AT HOME MARIJUANA TEST STRIP, SKU 900752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2022·2022-08-24

    First Response 2-Count Pregnancy Test Recalled for Improper Storage

    Family Dollar Stores is recalling First Response 2 CT pregnancy tests due to improper storage outside temperature-controlled areas. Affected products were sold nationwide between May 1 and June 10, 2022.

    Product
    FIRST RESPONSE 2 CT, SKU 902343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2022·2022-08-24

    Clear Eyes Contact Lens Drops Recalled for Improper Storage

    Family Dollar Stores is recalling Clear Eyes Contact Lens Drops Lubricating due to improper storage in non-temperature-controlled areas. The product was sold nationwide between May 1 and June 10, 2022.

    Product
    CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1558-2022·2022-08-24

    Sensis Signal Input Box recall for patient electrical leakage hazard with improper mounting

    Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.

    Product
    AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2022·2022-08-24

    Temporary Dental Filling Product Recalled for Improper Storage

    Family Dollar is recalling DENTEMP temporary dental filling products (SKU 902139) that were stored outside temperature-controlled conditions. The product was sold at Family Dollar stores nationwide between May and June 2022.

    Product
    DENTEMP ONE STEP .077OZ, SKU 902139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1357-2022·2022-08-24

    Stage 2-Ophardt Foaming Hand Sanitizer Recalled Due to Microbial Control Deviation

    Aire-Master of America Inc is recalling 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer due to manufacturing deviations in the water system's microbial control. Product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1547-2022·2022-08-24

    KY Jelly Lubricant Recalled for Improper Storage Conditions

    KY Jelly Lubricant 2 FL OZ (SKU 901443) distributed at Family Dollar stores was not stored in temperature-controlled areas. Consumers should discontinue use of product purchased between May–June 2022.

    Product
    KY JELLY LUBRICANT 2 FL OZ, SKU 901443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2022·2022-08-24

    Travel Kit Toothbrush and Toothpaste Recalled Due to Improper Storage

    Family Dollar is recalling approximately 1,555 travel kit toothbrush and toothpaste pouches that were stored in non-temperature-controlled areas. Products sold between May 1 and June 10, 2022 are affected.

    Product
    TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1539-2022·2022-08-24

    Poligrip Denture Adhesive Products Recalled for Improper Storage Conditions

    Family Dollar Stores recalls multiple Poligrip denture adhesive products due to improper storage outside temperature-controlled areas. Affected products were sold between May 1 and June 10, 2022.

    Product
    POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2022·2022-08-24

    VeriQuick Pregnancy Tests Recalled Due to Improper Storage

    Family Dollar is recalling VeriQuick pregnancy tests that were not stored in temperature-controlled areas between April-June 2022. Improper storage conditions may affect test accuracy.

    Product
    VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V636000·2022-08-23

    Indian FTR 1200 S Motorcycles Recalled for Coolant Junction Leak Risk

    Indian Motorcycle Company is recalling certain FTR 1200 and FTR 1200 S motorcycles due to a coolant junction that may leak, posing burn and crash risks to riders.

    Product
    INDIAN — INDIAN FTR 1200 RALLY, FTR1200, FTR 1200 S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08232022-01·2022-08-23

    Perdue Frozen Gluten-Free Chicken Tenders Alerted for Foreign Material Contamination

    USDA issued a public health alert for Perdue frozen gluten-free chicken tenders due to potential contamination with plastic and blue dye. No illnesses have been reported.

    Product
    Perdue Foods LLC — FSIS Issues Public Health Alert for Perdue Frozen Ready-To-Eat Chicken Tender Products Due to Foreign Material Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22E070000·2022-08-23

    Firefly Recalls Multiplex Electronic Control Modules for Unintended Awning Movement

    Firefly Integrations is recalling certain Multiplex Electronic Control Modules (ECM) because software defects may cause vehicle awnings to move unintentionally while parked, increasing the risk of injury.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V634000·2022-08-19

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Seat Barrier Defect

    Daimler Trucks North America is recalling 2011-2021 Thomas Built Saf-T-Liner HDX school buses because forward seat barriers may not provide sufficient protection, increasing injury risk in crashes.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V635000·2022-08-19

    Indian Motorcycle Recalls 28,689 Models for Electrical Connection Failure

    Indian Motorcycle is recalling 28,689 motorcycles from 2014-2020 because a failing electrical connection may cause loss of front lights, increasing crash risk.

    Product
    INDIAN — INDIAN CHIEFTAIN DARK HORSE, CHIEFTAIN, CHIEF VINTAGE, SPRINGFIELD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22202·2022-08-18

    Hard Rock Cafe Children's Hooded Sweatshirts Recalled for Strangulation Hazard

    Hard Rock Cafe is recalling about 1,550 children's hooded sweatshirts with drawstrings in the hood that can become entangled or caught on objects, posing a strangulation hazard to children. No injuries have been reported.

    Product
    Hard Rock Cafe Children's Hooded Sweatshirts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08182022-01·2022-08-18

    Hawaii Beef Producers Ground Beef Alert for E. coli O157:H7

    USDA issued a public health alert for specific 'Hawaii Big Island Beef' ground beef products due to possible E. coli O157:H7 contamination. No illnesses have been reported.

    Product
    Hawaii Beef Producers, LLC — FSIS Issues Public Health Alert for Ground Beef Products Due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·22V632000·2022-08-18

    2022-2023 Hyundai Elantra Airbag Emblem Detachment Safety Recall

    Hyundai is recalling certain 2022-2023 Elantra vehicles due to an improperly welded driver's airbag cover emblem that may detach during deployment and strike occupants, increasing injury risk.

    Product
    HYUNDAI — HYUNDAI ELANTRA N, ELANTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V633000·2022-08-18

    2020-2022 Hyundai Palisade vehicles recalled for tow hitch fire

    Hyundai is recalling 2020-2022 Palisade vehicles with tow hitch harnesses that may accumulate debris and moisture, causing electrical shorts and fire risk. Dealers will install replacement fuses and wire kits.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22201·2022-08-18

    ASUS ROG Maximus Z690 Hero Motherboards Recalled for Fire and Burn Hazards

    ASUS Computer International is recalling about 10,000 ASUS ROG Maximus Z690 Hero motherboards because a capacitor installed in reverse position can cause short circuits, overheating, or melting. ASUS has received 10 reports of overheating and melting, though no injuries have been reported.

    Product
    ASUS ROG Maximus Z690 Hero Motherboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1399-2022·2022-08-17

    FDA Recalls 3.95 Million Viral Transport Containers Distributed Without Clearance

    The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1542-2022·2022-08-17

    Big Olaf frozen ice cream recalled for potential Listeria monocytogenes contamination

    Big Olaf frozen ice cream products in all flavors and sizes distributed in Florida and Ohio are being recalled due to potential Listeria monocytogenes contamination. Listeria can cause serious illness.

    Product
    Big Olaf, Frozen Ice Cream to include all flavors, sold in sizes 2.5 gal, 1/2 gal, and pints packaged in plastic containers.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·22E069000·2022-08-17

    S&B Diesel Fuel Tank Recall for Insufficient Driveline Clearance

    S&B Filters is recalling certain diesel fuel tanks for RAM Mega Cab vehicles due to insufficient clearance that may cause fuel leaks and fire risk.

    Product
    FUEL SYSTEM, DIESEL:STORAGE:TANK ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1487-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy

    Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators may deliver reduced shock energy

    Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.

    Product
    Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1485-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy

    Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1400-2022·2022-08-17

    Viral Transport Container Distributed Without FDA Clearance or Guidance Compliance

    Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1398-2022·2022-08-17

    FDA Recalls Viral Transport Containers Distributed Without Clearance

    FDA recalls approximately 8.7 million viral transport containers that were distributed without regulatory clearance and without complying with FDA guidance for proper viral transport specifications.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1488-2022·2022-08-17

    Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy

    Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2022·2022-08-17

    Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect

    Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1489-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy

    Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.

    Product
    Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1311-2022·2022-08-17

    Triple Antibiotic Ointment Recalled Due to Improper Storage

    McKesson Medical-Surgical Inc. is recalling Triple Antibiotic Ointment due to storage deviations that violated drug label specifications and current good manufacturing practices.

    Product
    Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V630000·2022-08-17

    PACCAR Recalls 2021 Peterbilt 220 and 2022 Kenworth K270 Trucks

    PACCAR is recalling 2021 Peterbilt 220 and 2022 Kenworth K270 trucks because software may prevent stability control commands from processing during regenerative braking, increasing crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 220, K270
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1310-2022·2022-08-17

    Lorazepam Injection Recalled for Out-of-Specification Impurities and Degradation

    Hikma Pharmaceuticals is recalling 82,700 vials of Lorazepam Injection due to failed quality specifications for impurities and degradation. Lot #070096 (expired July 2023) was distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1330-2022·2022-08-17

    Prednisone Tablets Recalled for Contamination With Wrong-Strength Tablets

    Strides Pharma is recalling Prednisone 20 mg tablets due to contamination with 2.5 mg tablets. No illnesses have been reported, but patients may receive incorrect doses.

    Product
    PREDNISONE — PREDNISONE (PREDNISONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V631000·2022-08-17

    2023 Kenworth and Peterbilt trucks recalled for engine control failure

    PACCAR Incorporated is recalling certain 2023 Kenworth and Peterbilt commercial trucks because the engine control module may short-circuit, causing the engine to stall unexpectedly. An engine stall while driving increases the risk of a crash.

    Product
    PETERBILT — PETERBILT, KENWORTH 520, 579, T680, T800B
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1539-2022·2022-08-17

    Natierra Organic Freeze-Dried Blueberries Recalled for Lead Contamination

    Natierra Nature & Earth Organic Blueberries are recalled due to elevated lead levels detected by Maryland Department of Health testing. The recall affects 22,014 units distributed nationwide.

    Product
    Natierra Nature & Earth Organic Blueberries Ingredients: Organic Freeze-Dried Blueberries NET WT 12 oz (34g) Distributed by Natierra Van Nuys, CA 91405-1545 Certified Organics by SCS Global Services Product of US, Canada, Poland, Estonia, Romania
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V629000·2022-08-17

    2022 Genuine Scooter Handlebar Vibration May Cause Loss of Control

    Genuine Scooters is recalling certain 2022 NIU MQiGT EVO scooters due to excessive handlebar vibration. The vibration may cause rider fatigue or loss of vehicle control, increasing crash risk.

    Product
    GENUINE SCOOTER — GENUINE SCOOTER NIU MQIGT EVO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2022·2022-08-17

    Xhibit Telemetry Receiver Model 96280 alarm escalation software defect

    Xhibit Telemetry Receiver Model 96280 units fail to escalate critical alarms after approximately 25 days of continuous use, including signal loss, low battery, and SpO2 sensor issues. Caregivers may not be aware of device failures.

    Product
    Xhibit Telemetry Receiver, Model: 96280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1538-2022·2022-08-17

    Clear American Sparkling Water Recalled for Undeclared Coconut Allergen

    Clear American brand Strawberry Punch Snow Cone sparkling water is being recalled because it may contain undeclared coconut. The product is distributed across 14 states and should not be consumed by people with coconut allergies.

    Product
    Clear American brand "Strawberry Punch Snow Cone" flavored sparkling water beverage with other natural flavors; 1-liter clear plastic bottles. Best if Used by dates in August-October 2022.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Drugs)·D-1315-2022·2022-08-17

    Eye-stream Eye Wash Solution Recalled for Improper Storage

    Mckesson Medical-Surgical has recalled Eye-stream eye wash solution nationwide due to storage conditions outside drug label specifications.

    Product
    Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1307-2022·2022-08-17

    Lorazepam injection vials recalled nationwide for manufacturing specification failures

    Hikma Pharmaceuticals is recalling approximately 4.7 million vials of Lorazepam injection nationwide after finding out-of-specification related compounds during quality testing. The affected lots expire between June and August 2023.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1326-2022·2022-08-17

    FDA Recalls Sterile Alcohol Prep Pads Due to Improper Storage

    Mckesson Medical-Surgical is recalling ALCOHOL PREP sterile alcohol prep pads nationwide because they were stored outside manufacturer specifications, potentially compromising sterility. FDA classified this as a Class II recall.

    Product
    ALCOHOL PREP — ALCOHOL PREP (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2022·2022-08-17

    FDA Recalls 3D Systems VSP Scapula Marking Guide Due to Design Defect

    Medical Modeling, Inc. is recalling the 3D Systems VSP Reconstruction Scapula Marking Guide (Model VSPR-301) because it was incorrectly designed. The device was distributed internationally, including to Germany.

    Product
    3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1516-2022·2022-08-17

    Aeos Robotic Digital Microscope software errors affect autofocus and rebalancing

    Aesculap is recalling Aeos Robotic Digital Microscopes (versions 2.7 or earlier) due to application errors affecting rebalancing, recovery, and autofocus. Five units were distributed in Arkansas, Indiana, Nebraska, and North Carolina.

    Product
    Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1509-2022·2022-08-17

    MetaFix hip stem mislabeled with wrong size and batch information

    A Corin MetaFix hip stem (size 7 collarless) was incorrectly labeled as a size 3 collared stem with wrong batch information. The labeling error creates risk during surgical implantation.

    Product
    Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2022·2022-08-17

    Lithotripsy Generator Recall Due to Mis-Wired Component Affecting System Reliability

    Olympus Corporation recalls 2 units of the ShockPulse-SE Lithotripsy Generator due to a mis-wired component that causes improper power supply noise and EMC non-compliance, potentially affecting device reliability and treatment delivery.

    Product
    ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2022·2022-08-17

    GE Healthcare CT, PET, and NM Patient Tables May Drop During Service

    GE Healthcare patient tables used in CT, PET, and NM systems can drop during service if technicians remove incorrect screws without appropriate supports, potentially injuring service personnel.

    Product
    Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2022·2022-08-17

    Roche cobas e801 Analyzer Recall: Software Defect Affects Test Results

    Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.

    Product
    cobas e801 Immunoassay Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1507-2022·2022-08-17

    Haiou Needle Retractable Safety Syringe recalls due to needle detachment risk

    Approximately 7,218,000 Haiou Needle Retractable Safety Syringes are being recalled due to needle detachment and retracting mechanism failures that increase needlestick injury risk. The affected product was distributed in California.

    Product
    Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2022·2022-08-17

    HAIOU Retractable Safety Syringes Recalled for Needle Detachment Risk

    HAIOU retractable safety syringes are recalled due to reports of needle detachment from the syringe after injection and failure to retract, increasing needle stick injury risk. Approximately 4.05 million units are affected.

    Product
    HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-25G25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1332-2022·2022-08-17

    Fentanyl Citrate IV Bags Recalled Due to Sterility Assurance Failure

    SterRx is recalling 360 bags of fentanyl citrate IV medication due to lack of assurance of sterility. No illnesses have been reported.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1541-2022·2022-08-17

    Whey Protein Powder Recalled for Undeclared Milk Allergen

    Nature's Sunshine Products is recalling Aivia Whey Protein+ Power Herbs Vanilla Bean due to missing milk allergen declaration on the label. Consumers with milk allergies may be at risk.

    Product
    Aivia Whey Protein+ Power Herbs Vanilla Bean, NET WT. 1.33 LBS (602 G) Manufactured by Nature s Sunshine Products, Inc. 1655 N Main Street Spanish Fork, Utah 84660. UPC 0 99904 22712 5 Label is read in parts: "***INGREDIENTS: Whey Isolate, Whey Concentration***".
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1543-2022·2022-08-17

    Organic Amaranth Recalled for Potential Salmonella Contamination

    Smirks Ltd is recalling Organic Amaranth due to potential Salmonella contamination. The product was distributed across multiple states.

    Product
    Organic Amaranth, item # 4602, packaged in 25kg and supersack totes. Product is raw grain and imported from India. Store in cool, dry, dark place preferably below 15 Celsius.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1540-2022·2022-08-17

    Aivia Whey Protein Chocolate Recalled for Undeclared Milk Allergen

    Nature's Sunshine Products is recalling Aivia Whey Protein+ Power Herbs Chocolate because the label declares whey but fails to declare milk. Approximately 2,747 bags were distributed nationwide.

    Product
    Aivia Whey Protein+ Power Herbs Chocolate, NET WT 1.35 LBS (611 G) Manufactured by Nature s Sunshine Products, Inc. 1655 N Main Street Spanish Fork, Utah 84660. UPC 0 99904 22711 8 Label is read in parts: "***INGREDIENTS: Whey Isolate, Whey Concentration***".
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1317-2022·2022-08-17

    FDA Recalls ZADITOR Eye Drops Due to Improper Storage Conditions

    ZADITOR eye drops were stored outside FDA label specifications in a nationwide Class II recall affecting 9 boxes distributed by McKesson Medical-Surgical Inc.

    Product
    ZADITOR — ZADITOR (KETOTIFEN FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1328-2022·2022-08-17

    Difluprednate eye drops recalled for defective container closure affecting sterility

    Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.

    Product
    DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1313-2022·2022-08-17

    Eye Drops Recalled Due to Improper Storage Violating Manufacturing Standards

    Naphcon A eye drops are being recalled nationwide because products were stored outside label specifications, violating Current Good Manufacturing Practice (CGMP) standards.

    Product
    NAPHCON A — NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1331-2022·2022-08-17

    FentaNYL Citrate IV solution recalled due to sterility assurance concerns

    SterRx is recalling FentaNYL Citrate intravenous bags (10 mcg/mL) due to lack of assurance of sterility. The recalled lot (CHI, expiring December 2022) was distributed nationwide.

    Product
    FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1324-2022·2022-08-17

    Asthmanefrin Racephinephrine Inhalation Solution Recalled Due to Improper Storage

    Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.

    Product
    Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1319-2022·2022-08-17

    FDA Recalls Miralax Osmotic Laxative Powder for Storage Deviations

    The FDA recalled 67 bottles of Miralax laxative powder due to storage conditions that violated drug label specifications. The precautionary recall is due to potential product quality concerns from improper storage conditions.

    Product
    MIRALAX — MIRALAX (POLYETHYLENE GLYCOL 3350)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1325-2022·2022-08-17

    Racepinephrine Inhalation Solution Recalled for Improper Storage Conditions

    Mckesson Medical-Surgical is recalling S2 Racepinephrine Inhalation Solution due to storage that deviated from label specifications. This Class II recall affects 23 cartons distributed nationwide.

    Product
    S2 — S2 (RACEPINEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1305-2022·2022-08-17

    Prescription Drug Recall: Telmisartan-Hydrochlorothiazide Tablets Due to Defective Packaging

    Glenmark Pharmaceuticals recalls 72,288 units of Telmisartan-Hydrochlorothiazide 80/25 mg tablets nationwide due to defective blister packaging that is difficult to open and causes tablets to break.

    Product
    TELMISARTAN AND HYDROCHLOROTHIAZIDE — TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1314-2022·2022-08-17

    FDA Recalls SYSTANE Lubricant Eye Drops Due to Improper Storage

    McKesson Medical-Surgical Inc. is recalling 47 bottles of SYSTANE Lubricant Eye Drops nationwide. The products were stored outside label specifications, violating manufacturing practices.

    Product
    SYSTANE LUBRICANT — SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2022·2022-08-17

    Eye Drops Recalled for Improper Storage Outside Specifications

    SYSTANE BALANCE lubricant eye drops (12 boxes, nationwide) are being recalled because they were stored outside the manufacturer's label specifications. The FDA classified this as a Class II recall.

    Product
    SYSTANE BALANCE — SYSTANE BALANCE (PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2022·2022-08-17

    Earwax Removal Aid Debrox Recalled Nationwide for Improper Storage Conditions

    Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.

    Product
    DEBROX — DEBROX (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2022·2022-08-17

    FDA Recalls A&D Original Ointment due to improper storage conditions

    A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.

    Product
    A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1508-2022·2022-08-17

    Cholestech LDX cholesterol test cassettes require bilirubin interference label update

    Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.

    Product
    The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Drugs)·D-1329-2022·2022-08-17

    Lamotrigine Tablets Recalled for Label Strength Error

    AVKARE Inc. is recalling 8,328 bottles of Lamotrigine Tablets, USP 100 mg nationwide due to a labeling error in the declared strength.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1306-2022·2022-08-17

    Glenmark Pharmaceuticals Recalls Telmisartan/Hydrochlorothiazide Due to Defective Blister Packs

    Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Telmisartan and Hydrochlorothiazide tablets due to complaints of defective blister packs that are difficult to open and cause tablets to break during removal.

    Product
    TELMISARTAN AND HYDROCHLOROTHIAZIDE — TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1312-2022·2022-08-17

    Bisacodyl suppositories recalled nationwide due to improper storage

    McKesson Medical-Surgical is recalling Bisacodyl suppositories stored outside label specifications. The FDA Class II recall affects 45 boxes distributed nationwide.

    Product
    BISACODYL — BISACODYL (BISACODYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2022·2022-08-17

    FDA Recalls Dakin's Solution Due to Storage Condition Deviations

    McKesson Medical-Surgical recalled 113 bottles of Dakin's Solution (sodium hypochlorite) nationwide due to improper storage outside label specifications. Products may have compromised stability.

    Product
    DAKINS QUARTER — DAKINS QUARTER (SODIUM HYPOCHLORITE)
    Category
    Drug
    Distribution
    Distributed nationwide

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