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Showing 141–160 of 3363 results

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Carboxymethylcellulose Eye Drops (AvKARE) – label mix-up (2024)

LABELING: LABEL MIX-UP

FDADec 18, 2024Nationwide• AvKARE

Keith Valley Mustard (Clements) - Salmonella Contamination (2024)

Ingredient (mustard seeds) tested positive for Salmonella

FDADec 17, 2024AR, IN, KS +2 more• Clements Foods Co

Atropine Sulfate Ophthalmic Solution (Somerset) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

Class IIILow

FDADec 16, 2024Nationwide• SOMERSET THERAPEUTICS LLC

Acetaminophen Tablets (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg 1000ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 50mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 25mg 100ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 25mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Regular Strength (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Mi More Snacks (San Miguel) – Labeling Issue (2024)

Undeclared Allergen

Undeclared color on label

FDADec 4, 2024NJ• San Miguel Nuts Corp.

An Pan Bun (Oyatsupan Bakers) – Undeclared sesame (2024)

The contains statement does not declare sesame. Black sesame seeds are visible on product and the Ingredients Statement declares black sesame seeds.

FDANov 27, 2024IN, OR, WA• OYATSUPAN BAKERS

Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

FDANov 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Esomeprazole Oral Suspension (Zydus) – Incorrect NDC Number (2024)

Labeling: Not Elsewhere Classified - Wrong NDC number

FDANov 14, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Hydralazine HCl Tablets (Major Pharmaceuticals) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

FDANov 5, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

IBU Tablets (Dr. Reddy's) – Failed Specifications (2024)

Failed Tablet/Capsule Specifications

FDAOct 29, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Triamcinolone Cream (Padagis) – Potency Specification (2024)

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

FDAOct 11, 2024Nationwide• Padagis US LLC

Ciclopirox Gel (Glenmark) – Broken Tube Seal (2024)

Defective Container: Firm received complaints of broken tube at the seal.

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

Great Value Cherry Mixed Fruit (Walmart) – Undeclared Food Coloring (2024)

FD&C Red No 3 was not declared as an ingredient.

FDASep 26, 2024Nationwide• Walmart Inc

Great Value Diced Fruit Variety Pack (Walmart) – Undeclared Food Coloring (2024)

FD&C Red No 3 was not declared as an ingredient.

FDASep 26, 2024Nationwide• Walmart Inc

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