Warning letter / Centaur / July 2023 / C
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL is indicated for the prophylaxis of
Abbot recalls all batches of Digene Gel of all flavours (Mint, Orange, Mix fruit flavours)
Bottles of Digoxin Tablets, USP 0.125mg are incorrectly labelled and contain Digoxin Tablets USP, 0.25mg
Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per
Strides recalled 2700 bottles of Losartan Potassium USP 25 mg tablets in US for presence
In May 2023, Sun Pharma initiated recall of two lots of antidepressant drug Bupropion Hydrochloride