Drug product
Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
D-0477-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 g
- Official record key
drug-enforcement:D-0477-2018
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) 050715-2, Exp. 04/30/2019; b) 050715-2, Exp. 04/30/2019; c) 050715-1, Exp. 04/30/2019.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations