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Showing 101–120 of 216 results

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

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

Class IIILow

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

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

Failed Impurities/Degradation Specifications

Class IIILow

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

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

Labeling: Not Elsewhere Classified - Wrong NDC number

Class IIILow

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

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

Failed Tablet/Capsule Specifications

Class IIILow

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

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

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

Class IIILow

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

Adult Cough Medicine (Denison) – Crystallization Issue (2024)

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Class IIILow

FDASep 25, 2024Nationwide• Denison Pharmaceuticals, LLC

Kids Cough Medicine (Denison) – Crystallization Issue (2024)

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Class IIILow

FDASep 25, 2024Nationwide• Denison Pharmaceuticals, LLC

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Discoloration

Class IIILow

FDAAug 24, 2024Nationwide• Rubicon Research Private Limited

MySyrup Coconut (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Peppermint (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MyChai Chai Tea Concentrate (My Chai Inc) – Production Record Issue (2024)

Acidified Chai Tea product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Sugar Free Caramel (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

Oregon Orchards Banana Mix (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Salted Caramel (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Sugar Free Vanilla (My Chai Inc) – Production Record Issue (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Raspberry (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Almond (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MyChai Chai Tea Concentrate (My Chai) – Production Record (2024)

Acidified Chai Tea product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MyChai Super Chai Tea (My Chai) – Production Record (2024)

Acidified Chai Tea product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Hazelnut (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

Class IIILow

FDAAug 21, 2024Nationwide• My Chai Inc

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