Drug product
Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
D-0530-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2100 g
- Official record key
drug-enforcement:D-0530-2018
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) 062615-1, Exp. 06/09/2018; 071816-1, exp. 06/05/2019; b) 043015-1, Exp. 04/01/2018; 062615-1, Exp. 06/09/2018; 071816-1, exp. 06/05/2019; c) 062615-1, Exp. 06/09/2018; 071816-1, Exp. 06/05/2019.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations