Quality/GMPs

Articles

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person. 

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

Pfizer Issues Voluntary Nationwide Recall of Lots of Accupril

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL

Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.

Pfizer Issues Voluntary Recall of Blood Pressure Tablets Due to High Levels of Nitrosamine

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

Mylan Recalls Semglee Prefilled Pens

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

Contaminant in Moderna Vaccines in Japan Suspected to be Metallic Particles

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine. 

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots 

Sagent Pharmaceuticals is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL) to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product. 

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall for its Low Blood Pressure Treatment

Due to a packaging error, the company is voluntarily recalling one lot of sildenafil 100 mg tablets for the treatment of erectile dysfunction and one lot of trazodone 100mg tablets for the treatment of major depressive disorder.  

Adverse Events and Recalls