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Showing 4261–4280 of 14370 results

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Lisinopril Tablets (Lupin) – Product Mix Up (2020)

Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.

Class IIModerate

FDAMay 28, 2020Nationwide• Lupin Pharmaceuticals Inc.

Metformin Hydrochloride Extended-Release Tablets (Apotex) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels

Class IIModerate

FDAMay 27, 2020Nationwide• Apotex Inc.

Duavee Tablets (Pfizer) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIILow

FDAMay 27, 2020Nationwide• Pfizer Inc.

Olanzapine Tablets (Aurobindo) – Impurity Specs (2020)

Failed Impurities/ Degradation Specifications

FDAMay 26, 2020Nationwide• Aurobindo Pharma USA Inc.

Clonidine Hydrochloride Tablets (Unichem) – Benzophenone Migration (2020)

Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.

FDAMay 26, 2020Nationwide• UNICHEM PHARMACEUTICALS USA INC

Olanzapine Tablets (Aurobindo Pharma) – Failed Impurity Test (2020)

Failed Impurities/ Degradation Specifications

FDAMay 26, 2020Nationwide• Aurobindo Pharma USA Inc.

Lamotrigine Tablets (Jubilant Cadista) – Foreign Substance Risk (2020)

Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.

FDAMay 26, 2020TN• Jubilant Cadista Pharmaceuticals, Inc.

NP Thyroid 30 (Acella) – Superpotent Drug (2020)

Superpotent Drug.

FDAMay 22, 2020Nationwide• Acella Pharmaceuticals, LLC

Dextroamphetamine Tablets (Teva) – Mixed Strength Bottles (2020)

Some bottles may contain mixed strengths of the product.

Class IIModerate

FDAMay 22, 2020Nationwide• Teva Pharmaceuticals USA

NP Thyroid 60 (Acella) – Superpotent Drug (2020)

Superpotent Drug.

FDAMay 22, 2020Nationwide• Acella Pharmaceuticals, LLC

Dextroamphetamine Tablets (Teva) – Mixed Strength Bottles (2020)

Some bottles may contain mixed strengths of the product.

Class IIModerate

FDAMay 22, 2020Nationwide• Teva Pharmaceuticals USA

NP Thyroid 90 (Acella) – Superpotent Drug (2020)

Superpotent Drug.

FDAMay 22, 2020Nationwide• Acella Pharmaceuticals, LLC

Dextroamphetamine Tablets (Teva) – Mixed Strength Bottles (2020)

Some bottles may contain mixed strengths of the product.

Class IIModerate

FDAMay 22, 2020Nationwide• Teva Pharmaceuticals USA

Doxycycline Tablets (Harvard Drug) – Failed Dissolution (2020)

Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.

Class IIModerate

FDAMay 22, 2020Nationwide• The Harvard Drug Group

LidoPro Patch (Wuhan Bingbing) – Manufacturing Records Lost (2020)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Class IIModerate

FDAMay 19, 2020Nationwide• Wuhan Bingbing Pharmaceutical Co., Ltd.

Zilretta Injection (Flexion) – Temperature Abuse (2020)

Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded

FDAMay 19, 2020Nationwide• Flexion Therapeutics, Inc.

LidoPatch (Wuhan Bingbing) – Manufacturing Records Lost (2020)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Class IIModerate

FDAMay 19, 2020Nationwide• Wuhan Bingbing Pharmaceutical Co., Ltd.

Mencaine Patch (Wuhan Bingbing) – Manufacturing Records Lost (2020)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Class IIModerate

FDAMay 19, 2020Nationwide• Wuhan Bingbing Pharmaceutical Co., Ltd.

Lidocaine Cold & Hot Patch (Wuhan Bingbing) – Manufacturing Records Lost (2020)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Class IIModerate

FDAMay 19, 2020Nationwide• Wuhan Bingbing Pharmaceutical Co., Ltd.

Doxycycline Tablets (American Health) – Failed Dissolution (2020)

Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).

Class IIModerate

FDAMay 19, 2020Nationwide• American Health Packaging

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