Quality Systems

Meg Rivers is the former senior editor for 

Articles

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

The Real Danger of Substandard and Counterfeit COVID-19 Vaccines

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

KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.

Atovaquone Oral Suspension Recalled

The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.

Teva Recalls Product Due to Particulate Matter

The company is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL because of incorrect labeling.

Hospira Recalls Anesthesia Medicines Due to Mislabeling

The company is recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of visible particulates.

Hospira Recalls Sterile Water for Injection 

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 

Feliza Mirasol is the science editor for 

A slew of solid-dose drug recalls were issued over the course of 2020 and in early 2021 after nitrosamine contamination was found in products.

Pharma Industry Contends with Contamination-Based Recalls

The company is recalling the product because of crystallization in vials.

Zydus Pharmaceuticals (USA) Inc. Recalls Acyclovir Sodium Injection, 50 mg/mL 

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. 

Adverse Events and Recalls