Quality Systems

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.


Keeping Toxicity to a Minimum

A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.

Study Finds Dose-Dependent Persistent Visual Side Effects with Sildenafil

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

Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.

Mirtazapine Tablets Recalled

Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).

Glenmark Pharmaceuticals Recalls Ranitidine Tablets

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

The company is recalling Alprazolam Tablets, USP C-IV 0.5 mg because of potential presence of foreign substance.

Mylan Recalls Alprazolam Tablets

Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.

Pfizer Recalls Batches of Docetaxel Injection

Dr. Reddy’s, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.

Three More Companies Issue Recalls Due to NDMA Impurities

Agnes Shanley is senior editor of Pharmaceutical Technology.

The root cause of NDMA contamination may go well beyond manufacturing problems, to the molecule itself.

Adverse Events and Recalls