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Showing 2461–2480 of 14370 results

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Acetaminophen Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Calcium Carbonate Suspension (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Acetaminophen Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Acetaminophen Children's Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Magnesium Aluminum Simethicone MAX (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Diphenhydramine HCl Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Guaifenesin Dextromethorphan Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Milk of Magnesia USP (Plastikon Healthcare) – Microbial Contamination (2022)

Microbial Contamination of Non-Sterile Products

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Losartan Potassium 50mg (PD-Rx Pharmaceuticals) – Impurity Levels (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAJun 6, 2022Nationwide• PD-Rx Pharmaceuticals, Inc.

Losartan Potassium Tablets (PD-Rx Pharmaceuticals) – CGMP Impurity Deviation (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAJun 6, 2022Nationwide• PD-Rx Pharmaceuticals, Inc.

Losartan Potassium 100mg (PD-Rx Pharmaceuticals) – Impurity Levels (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAJun 6, 2022Nationwide• PD-Rx Pharmaceuticals, Inc.

Testosterone Cypionate Injection (Sun Pharma) – Machinery Abnormality (2022)

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Cypionate Injection (Sun Pharma) – Manufacturing API Issues (2022)

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Clonazepam Orally Disintegrating Tablets (Sun Pharma) – Oversized Tablet (2022)

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Ortiga Ajo Rey Tablets (Amazon) – Undeclared Diclofenac (2022)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

FDAMay 26, 2022Nationwide• Amazon.com, Inc.

Ethanol Injection (US Specialty) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 24, 2022Nationwide• US Specialty Formulations LLC

Tegsedi Injection (Akcea) – Superpotent Formulation (2022)

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

FDAMay 23, 2022KY• Akcea Therapeutics, Inc.

Glycopyrrolate Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Glycopyrrolate Injection (Nephron) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 18, 2022Nationwide• Nephron Sterile Compounding Center LLC

Alprostadil Injection (Teva) – Impurity Specs (2022)

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

FDAMay 18, 2022Nationwide• Teva Pharmaceuticals USA Inc

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