GMPs

Indian Manufacturer Recalls Generics Due to Mix-Up

Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that one bottle of the drug contained 50 mg metoprolol tartrate tablets instead of the intended drug. Read More

Another Indian Company Warned For Extensive Quality Problems

The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of active pharmaceutical ingredient with conforming batches. Read More

Sagent Latest Drugmaker To Recall Leaky Injectables

Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More

Two Compounders Warned for Mixing Unapproved Drugs

The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More