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Showing 921–940 of 2326 results

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Array Liquid Antiseptic Handwash (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Genuine Joe Antibacterial Lotion Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Compliance Dishwashing Liquid Soap (Midlab) – Microbiological Contamination (2024)

cGMP Deviations: Out of specification results for micro in hand soap products.

Class IIModerate

FDANov 6, 2024Nationwide• Midlab Incorporated

Nestle Nutren 2.0 (Nestle Health Science) – Labeling Error (2024)

Labeling Error. Nutren 2.0 UltraPak pouches were mislabeled with an Isosource 1.5 label.

Class IIModerate

FDANov 5, 2024AZ, CA, FL +13 more• NESTLE HEALTH SCIENCE

Jarritos Coconut Water – Seal Compromise (2024)

The hermetic seal on the lid of the cans may be compromised

Class IIModerate

FDANov 4, 2024AL, AR, DE +26 more• Tipp Distributors, Inc. dba Novamex

Diltiazem Hydrochloride Capsules 60mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 120mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 120mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 90mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 60mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 90mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

O.G. Cookies (Legally Addictive) – Rancid Taste (2024)

The firm received complaints of a "rancid taste" from consumers.

Class IIModerate

FDAOct 31, 2024IL, PA• Legally Addictive Foods

Xelstrym (Noven) – Defective Delivery System (2024)

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Class IIModerate

FDAOct 31, 2024Nationwide• Noven Pharmaceuticals Inc

Regadenoson Injection (Baxter) – Missing Label (2024)

Labeling: Missing Label

Class IIModerate

FDAOct 30, 2024Nationwide• Baxter Healthcare Corporation

Dapsone Gel (Viona) – Crystallization (2024)

Crystallization

Class IIModerate

FDAOct 29, 2024Nationwide• VIONA PHARMACEUTICALS INC

Timolol Maleate Solution (FDC) – Defective Container (2024)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Class IIModerate

FDAOct 29, 2024IN, NJ• FDC Limited

Lanthanum Carbonate Tablets (Cipla) – Broken Tablets (2024)

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Class IIModerate

FDAOct 23, 2024Nationwide• Cipla USA, Inc.

Lanthanum Carbonate Tablets (Cipla) – Broken Tablets (2024)

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Class IIModerate

FDAOct 23, 2024Nationwide• Cipla USA, Inc.

Morphine Sulfate Tablets 30mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

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

Morphine Sulfate Tablets 15mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

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

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