Drug product
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
D-0506-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166000 g
- Official record key
drug-enforcement:D-0506-2018
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) 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; b) 020116-2, Exp. 12/13/2020; 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; c) 020116-1, 020116-2, Exp. 12/13/2020; 021115-1, exp. 01/15/2020; 080415-1, Exp. 03/22/2020; 082416-1, 082416-2 Exp. 01/31/2021.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations