Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Temperature excursion in transport cause

Baxter initiated recall of one lot of Doxil (doxorubicin hydrochloride liposome injection) in U.S due

Potential cross contamination with ßlac

SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination

Hospira recall Injection products in US

Hospira recalled in US one lot of 4.2% Sodium bicarbonate injection and one lot each

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

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