Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

VistaPharm (USA) recall Sucralfate Oral

Florida based  VistaPharm LLC is recalling in US one lot of ulcer treatment drug Sucralfate

Warning letter / Centaur / July 2023 / C

Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing

Novartis recall one lot of Sandimmune®

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL is indicated for the prophylaxis of

Abbot recall all batches of Digene Gel o

Abbot recalls all batches of Digene Gel of all flavours (Mint, Orange, Mix fruit flavours)

Marlex Pharmaceuticals, US, recall one l

Bottles of Digoxin Tablets, USP 0.125mg are incorrectly labelled and contain Digoxin Tablets USP, 0.25mg

Merck Animal Health (MSD) recalls three

Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It

Warning letter / Centaur / July 2023 / F

The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over

Accord (Intas) recall Multiple Injection

Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per

Strides recalls Losartan Potassium table

Strides recalled 2700 bottles of Losartan Potassium USP 25 mg tablets in US for presence