FDA (Drugs) recall action 86749
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
CGMP Deviations
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.
Shilpa Medicare Limited is recalling 4,166 bottles of Imatinib Mesylate 400 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Shilpa Medicare Limited is recalling 6,560 vials of Azacitidine for Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and nationwide.
Shilpa Medicare Limited is voluntarily recalling 2,611 bottles of Imatinib Mesylate 100 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations.
Shilpa Medicare Limited is recalling 2,008 vials of Docetaxel Injection USP due to Current Good Manufacturing Practice (CGMP) deviations.
Shilpa Medicare Limited is voluntarily recalling 2,064 vials of Busulfan Injection due to CGMP deviations. The recall is nationwide and the lot expired in December 2020.
Shilpa Medicare Limited is voluntarily recalling 35,931 vials of Azacitidine for Injection due to Current Good Manufacturing Practice (CGMP) deviations.