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Showing 2441–2460 of 14370 results

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Eszopiclone 1mg Tablets (Macleods) – Shortfill Risk (2022)

Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.

Class IIModerate

FDAJun 16, 2022Nationwide• Macleods Pharma Usa Inc

AloePro Aloe Vera Liquid (Premier Research Labs) - Spoilage Risk (2022)

Product spoiling over time; spoilage visible beneath lid/closure upon opening.

Class IIModerate

FDAJun 15, 2022Nationwide• Premier Research Labs LLC

Tretinoin Capsules (Teva) - Failed Dissolution Tests (2022)

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

Class IIModerate

FDAJun 14, 2022Nationwide• Teva Pharmaceuticals USA Inc

Fluticasone Nasal Spray (Akorn) - Defective Dispenser (2022)

Defective container: defect prevents product from dispensing as intended.

Class IIModerate

FDAJun 13, 2022Nationwide• Akorn, Inc.

Zileuton Extended-Release Tablets (Lupin) - Failed Dissolution (2022)

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

Class IIModerate

FDAJun 10, 2022Nationwide• Lupin Pharmaceuticals Inc.

Testosterone Cypionate Injection (Sun Pharma) - Sterility Risk (2022)

Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion

Class IIModerate

FDAJun 10, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Boric Acid Capsules (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Calcipotriene Scalp Solution (Akorn) - Defective Delivery (2022)

Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

Class IIModerate

FDAJun 10, 2022Nationwide• Akorn, Inc.

Losartan/Hydrochlorothiazide (Macleods) - Impurity Levels (2022)

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

Class IIModerate

FDAJun 10, 2022Nationwide• Macleods Pharma Usa Inc

Clonidine Patch (Mayne Pharma) - Delivery System Defect (2022)

Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.

Class IIModerate

FDAJun 9, 2022Nationwide• Mayne Pharma Inc

SnoreStop NasoSpray (Green Pharma) - Microbial Contamination (2022)

Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.

FDAJun 9, 2022Nationwide• Green Pharmaceuticals, Inc.

Magnesium Aluminum Simethicone MAX (Plastikon Healthcare) – Microbial Contamination (2022)

Microbial Contamination of Non-Sterile Products.

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Milk of Magnesia USP (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

CorrectDose Children's Pain Relief (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 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) – 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 (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 (Plastikon Healthcare) – Microbial Contamination (2022)

Microbial Contamination of Non-Sterile Products.

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

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