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Promethazine Codeine Syrup (Qualitest) – Impurity Concern (2015)

Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

Class IIILow

FDAMar 25, 2015Nationwide• Qualitest Pharmaceuticals

Glipizide Metformin Tablets (Heritage) – Unknown Impurity (2015)

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Class IIModerate

FDAMar 25, 2015Nationwide• Heritage Pharmaceuticals, Inc.

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Promethazine Codeine Syrup (Qualitest) – Impurity Concern (2015)

Glipizide Metformin Tablets (Heritage) – Unknown Impurity (2015)

Clinimix E (Baxter) – sterility concerns (2015)

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Gemcitabine Injection (Mylan) – particulate contamination (2015)

Sodium Chloride Injection (Baxter) – sterility concerns (2015)

Methotrexate Injection (Mylan) – Particulate Matter (2015)

Sodium Chloride Injection (Baxter) – Sterility Compromise (2015)

Dextrose Injection (Baxter) – Sterility Compromise (2015)

CARBOplatin Injection (Mylan) – Particulate Matter (2015)

Sulfamethoxazole Oral Suspension (Akorn) – Dissolution Failure (2015)

Sulfamethoxazole Trimethoprim Suspension (Akorn) – Dissolution Failure (2015)

Sulfamethoxazole Trimethoprim Suspension (Akorn) – Dissolution Failure (2015)

Klaire Labs Ther-Biotic Chewable (ProThera) – Glass shard contamination (2015)

Klaire Labs Ther-Biotic FACTOR 6 (ProThera) – glass contamination (2015)

Blue Bell Sour Pops Green Apple (Blue Bell) – Listeria Risk (2015)

Captopril Tablets (Wockhardt) – Thickness Specification Fail (2015)

Fexofenadine HCl Tablets (Mylan) – Impurity Concern (2015)

Lactated Ringer's Irrigation (Hospira) – Particulate Contamination (2015)