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Showing 8301–8320 of 15081 results

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Metformin Tablets (Ascend Labs) – Foreign Tablet Contamination (2016)

Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

Class IIModerate

FDANov 2, 2016AL, FL, GA +2 more• Ascend Laboratories LLC

Bupropion Hydrochloride Tablets (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications; 6 month time point

FDANov 2, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Qnasl Nasal Aerosol 80mcg (Teva) – Content Uniformity (2016)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

Class IIILow

FDANov 1, 2016Nationwide• Teva Pharmaceuticals USA

Fentanyl Citrate Injection (Hospira) – Sterility Concerns (2016)

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

Class IIModerate

FDANov 1, 2016Nationwide• Hospira Inc.

Qnasl Nasal Aerosol 40mcg (Teva) – Content Uniformity (2016)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

FDANov 1, 2016Nationwide• Teva Pharmaceuticals USA

Salsalate Tablets 500mg (Nationwide Laboratories) – CGMP Manufacturing Risk (2016)

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

Class IIModerate

FDAOct 28, 2016Nationwide• Nationwide Laboratories, LLC

Phenazopyridine Hydrochloride 200mg (Nationwide Laboratories) – CGMP Manufacturing Risk (2016)

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

Class IIModerate

FDAOct 28, 2016Nationwide• Nationwide Laboratories, LLC

Skinny Bee Diet Capsules (Love My Tru Body) – Undeclared Sibutramine (2016)

Undeclared Allergen

Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.

FDAOct 28, 2016Nationwide• Love My Tru Body

Phenazopyridine Hydrochloride 100mg (Nationwide Laboratories) – CGMP Manufacturing Risk (2016)

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

Class IIModerate

FDAOct 28, 2016Nationwide• Nationwide Laboratories, LLC

Salsalate Tablets 750mg (Nationwide Laboratories) – CGMP Manufacturing Risk (2016)

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

Class IIModerate

FDAOct 28, 2016Nationwide• Nationwide Laboratories, LLC

KENALOG Spray (Sun Pharmaceutical) – Stability Specification Failure (2016)

Failed Stability Specifications: Low Out of Specification results for alcohol content.

FDAOct 28, 2016Nationwide• Sun Pharmaceutical Industries, Inc.

Bupropion Hydrochloride XL 300mg (Amerisource) – Dissolution Specification Failure (2016)

Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.

FDAOct 27, 2016Nationwide• Amerisource Health Services

Indiomin MB Urinary Antiseptic Capsules (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Urolet MB Urinary Antiseptic Tablets (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Hyolev MB Urinary Antiseptic Tablets (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Phenazopyridine Hydrochloride 100mg (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Urophen MB Urinary Antiseptic Tablets (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Uramit MB Urinary Antiseptic Capsules (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Azuphen MB Urinary Antiseptic Capsules (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Phenazopyridine Hydrochloride 200mg (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

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