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Showing 661–680 of 14370 results

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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

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

lunaSOMM Supplement (DesBio) – Undeclared Soy (2024)

Product contains undeclared soy lecithin.

Class IIModerate

FDAOct 30, 2024Nationwide• Deseret Biologicals Inc

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

Failed Tablet/Capsule Specifications

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

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

Lisdexamfetamine Capsules (Lannett) – Content Uniformity (2024)

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

Class IIModerate

FDAOct 25, 2024Nationwide• Lannett Company Inc.

THERACARE Lidocaine Patch (Unexo) – cGMP Deviations (2024)

cGMP Deviations

Class IIModerate

FDAOct 24, 2024Nationwide• Unexo Life Sciences Private Limited

EQUATE Lidocaine Patch (Unexo) – cGMP Deviations (2024)

cGMP Deviations

Class IIModerate

FDAOct 24, 2024Nationwide• Unexo Life Sciences Private Limited

Ramipril Capsules 10mg (Lupin) – CGMP Source Issue (2024)

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Class IIModerate

FDAOct 23, 2024Nationwide• Lupin Pharmaceuticals 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.

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.

Ramipril Capsules 2.5mg (Lupin) – CGMP Source Issue (2024)

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Class IIModerate

FDAOct 23, 2024Nationwide• Lupin Pharmaceuticals Inc.

Ramipril Capsules 5mg (Lupin) – CGMP Source Issue (2024)

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Class IIModerate

FDAOct 23, 2024Nationwide• Lupin Pharmaceuticals 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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