Quality/GMPs

Articles

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.  

AvKARE Recalls Two Products After Packaging Mix-Up

Resolving drug shortages starts with identifying the source of the problem.

Pandemic-fighting Drugs in Shortage, Again

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

WuXi Biologics Provides Update on Operations in Light of Coronavirus Outbreak

According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.

FDA Releases Statement Regarding the Recall of Basic Reset and Biogenyx Products

FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.

Adverse Event Reporting for Compounded Drugs

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

FDA Expands Scope of API Impurity Investigation

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected. 

Heritage Pharmaceuticals Inc. Recalls Products Due to Sterility Failure

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act. 

Adverse Events and Recalls