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Showing 9821–9840 of 14370 results

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Clarithromycin 500mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Lisinopril 40mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Azithromycin 250mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Lisinopril 10mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Amlodipine Besylate 5mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Famotidine 20mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Amlodipine Besylate 2.5mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Azithromycin 600mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Zonisamide 100mg Capsules (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Azithromycin 500mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Losartan Potassium 100mg Tablets (Apotex) – Blend Uniformity Issue (2015)

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Class IIModerate

FDAMay 29, 2015Nationwide• Apotex Inc.

Enalapril-Hydrochlorothiazide 10/25mg Tablets (Apotex) – Blend Uniformity Issue (2015)

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Class IIModerate

FDAMay 29, 2015Nationwide• Apotex Inc.

Losartan Potassium 50mg Tablets (Apotex) - uniformity failure (2015)

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Class IIModerate

FDAMay 29, 2015Nationwide• Apotex Inc.

Losartan Potassium 25mg Tablets (Apotex) – Blend Uniformity Issue (2015)

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Class IIModerate

FDAMay 29, 2015Nationwide• Apotex Inc.

Ceftriaxone 2g Saline Bags (Lincare) – Sterility Not Assured (2015)

Lack of Assurance of Sterility: Sterility of product is not assured.

Class IIModerate

FDAMay 28, 2015Nationwide• Lincare, Inc.

Vancomycin IV Bag (Lincare) – sterility concern (2015)

Lack of Assurance of Sterility: Sterility of product is not assured.

Class IIModerate

FDAMay 28, 2015Nationwide• Lincare, Inc.

Diphenhydramine Syringe (Lincare) – sterility concern (2015)

Lack of Assurance of Sterility: Sterility of product is not assured.

Class IIModerate

FDAMay 28, 2015Nationwide• Lincare, Inc.

Total Parenteral Nutrition Bag (Lincare) – sterility concern (2015)

Lack of Assurance of Sterility: Sterility of product is not assured.

Class IIModerate

FDAMay 28, 2015Nationwide• Lincare, Inc.

Total Parenteral Nutrition Bag (Lincare) – sterility concern (2015)

Lack of Assurance of Sterility: Sterility of product is not assured.

Class IIModerate

FDAMay 28, 2015Nationwide• Lincare, Inc.

Vancomycin IV Bag (Lincare) – sterility concern (2015)

Lack of Assurance of Sterility: Sterility of product is not assured.

Class IIModerate

FDAMay 28, 2015Nationwide• Lincare, Inc.

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