FDA (Drugs) recall action 71331
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Blenheim Pharmacal is recalling 166 bottles of Captopril 50 mg tablets distributed in Indiana due to cGMP deviations and inadequate complaint investigations.
Blenheim Pharmacal is recalling 50 bottles of Clarithromycin Tablets 500 mg in Indiana due to cGMP deviations and inadequate complaint investigation.