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Showing 461–480 of 784 results

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Hard Steel Capsules (Supercore) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

FDAJul 12, 2024Nationwide• Supercore Products Group Inc.

Acetaminophen (Aurobindo) – Missing Label (2024)

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

FDAJul 11, 2024NJ, NY, PA• Aurobindo Pharma USA Inc

Acetaminophen Injection (Hikma) – Label Mix-up (2024)

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

FDAJul 8, 2024OH, PR• Hikma Pharmaceuticals USA Inc.

Potassium Chloride Capsules (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications

FDAJun 25, 2024Nationwide• Amerisource Health Services LLC

Deluxe Roasted Salted Mixed Nuts – Peanut Allergen (2024)

Undeclared Allergen

Undeclared allergen; peanuts

FDAJun 20, 2024AK, CA, ID +3 more• DSD Merchandisers, Inc.

Queso Fresco Cheese (La Hacienda) – Listeria contamination (2024)

Queso fresco was found to contain Listeria monocytogenes.

FDAJun 3, 2024IN, TX• Productos La Hacienda LLC

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

Suntegrity Sunscreen (Synchronicity) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Crab Cake (County Road Seafood) – Undeclared Egg (2024)

Undeclared Allergen

Product contains (allergen) undeclared egg.

FDAMay 15, 2024NC, SC• County Road Seafood, LLC

Aahu Barah Apricot Roll (Global Commodities) – Elevated Sulfites (2024)

Undeclared Allergen

Product contains elevated levels of undeclared sulfites.

FDAMay 10, 2024MD, MO, NY +3 more• Global Commodities Inc

Gibson Farms Organic Nuts (Gibson Farms) – E. Coli Risk (2024)

Potential E. coli O157:H7 contamination.

FDAApr 26, 2024CA, WA• Gibson Farms Inc

Tirzepatide (Revive Rx) – Labeling Mix-up (2024)

Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

FDAApr 20, 2024Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

Organic Black Chia Seeds (Walmart) – Salmonella Risk (2024)

Salmonella contamination

FDAApr 15, 2024AL, CA, CO +9 more• NATURAL SOURCING INTERNATIONAL,LLC

Sapropterin Dihydrochloride Powder (Dr. Reddy's) – Sub-potent Drug (2024)

Sub-potent Drug; powder discoloration associated with decreased potency

FDAApr 8, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Javygtor Oral Powder (Dr. Reddy's) – Sub-potent Drug (2024)

Sub-potent Drug; powder discoloration associated with decreased potency

FDAApr 8, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

ELV Control Herbal Supplement (World Green Nutrition) – Toxic Ingredient (2024)

FDA Analysis found product labeled as tejocote is actually yellow oleander, which is toxic to humans.

FDAApr 3, 2024DE, OR• World Green Nutrition Inc.

Deep South Tomato Pie (Robeson) – missing ingredient details (2024)

The firm was notified that the label did not list any sub ingredients. The product contains pimento cheese which is made with mayonnaise which may include eggs. Undeclared eggs.

FDAMar 26, 2024GA, NC, SC• Robeson Enterprises

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