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Showing 7881–7900 of 15081 results

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LaBri's Body Health Atomic (Envy Me) – undeclared ingredient (2017)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.

FDAMar 28, 2017Nationwide• Envy Me

Nystatin Triamcinolone Cream (Taro) – content uniformity (2017)

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

Class IIModerate

FDAMar 28, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Testosterone Micronized (Zizhu Pharmaceutical) – cGMP deviation (2017)

cGMP Deviations; lack of quality assurance.

Class IIModerate

FDAMar 24, 2017CO, MN, NJ +3 more• Qinhuangdao Zizhu Pharmaceutical, Co.

Estrone Micronized (Zizhu Pharmaceutical) – cGMP deviation (2017)

cGMP Deviations; lack of quality assurance.

Class IIModerate

FDAMar 24, 2017CO, MN, NJ +3 more• Qinhuangdao Zizhu Pharmaceutical, Co.

Ethinyl Estradiol Micronized (Qinhuangdao Zizhu) – Quality Assurance Issues (2017)

cGMP Deviations; lack of quality assurance.

Class IIModerate

FDAMar 24, 2017CO, MN, NJ +3 more• Qinhuangdao Zizhu Pharmaceutical, Co.

Estriol Micronized (Zizhu Pharmaceutical) – cGMP deviation (2017)

cGMP Deviations; lack of quality assurance.

Class IIModerate

FDAMar 24, 2017CO, MN, NJ +3 more• Qinhuangdao Zizhu Pharmaceutical, Co.

Estradiol Micronized (Zizhu Pharmaceutical) – cGMP deviation (2017)

cGMP Deviations; lack of quality assurance.

Class IIModerate

FDAMar 24, 2017CO, MN, NJ +3 more• Qinhuangdao Zizhu Pharmaceutical, Co.

Levonorgestrel Non-Micronized (Qinhuangdao Zizhu) – Quality Assurance Issues (2017)

cGMP Deviations; lack of quality assurance.

Class IIModerate

FDAMar 24, 2017CO, MN, NJ +3 more• Qinhuangdao Zizhu Pharmaceutical, Co.

Estradiol Non-Micronized (Qinhuangdao Zizhu) – Quality Assurance Issues (2017)

cGMP Deviations; lack of quality assurance.

Class IIModerate

FDAMar 24, 2017CO, MN, NJ +3 more• Qinhuangdao Zizhu Pharmaceutical, Co.

Muscle Meds Beef Protein (Armada) – Contamination Concern (2017)

A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.

Class IIModerate

FDAMar 23, 2017CO, NJ• Armada Nutrition

Olanzapine Tablets 20mg (Sun Pharmaceutical) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

FDAMar 22, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Olanzapine Tablets 10mg (Sun Pharmaceutical) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

FDAMar 22, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Pilocarpine Hydrochloride Solution (Novartis) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

FDAMar 22, 2017Nationwide• Novartis Pharmaceuticals Corp.

Isopto Carpine (Novartis) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

FDAMar 22, 2017Nationwide• Novartis Pharmaceuticals Corp.

Olanzapine Tablets 2.5mg (Sun Pharmaceutical) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

FDAMar 22, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Olanzapine Tablets 7.5mg (Sun Pharmaceutical) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

FDAMar 22, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Ventolin HFA (GlaxoSmithKline) – Defective Delivery System (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

Class IIModerate

FDAMar 22, 2017Nationwide• GlaxoSmithKline, LLC

Atorvastatin Calcium Tablets 10mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 21, 2017Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

CLENZIderm Pore Therapy (Valeant) – Product Discoloration (2017)

Discoloration.

FDAMar 20, 2017Nationwide• Valeant Pharmaceuticals North America LLC

Atorvastatin Calcium Tablets 80mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

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