Drug product
Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
D-0508-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22900 g
- Official record key
drug-enforcement:D-0508-2018
Official wording
Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Code information: Lot #: a) 110515-2, Exp. 09/30/2018; b) 110515-1, Exp. 09/30/2018; c) 110515-1, Exp. 09/30/2018.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations