Drug product
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
D-0493-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 193000 g
- Official record key
drug-enforcement:D-0493-2018
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) 062915-2, Exp. 04/30/2020; b) 022416-1, Exp. 11/30/2020; 062915-2, exp. 04/30/2020; 081215-2, Exp. 06/30/2020; c) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; d) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; 110415-1, Exp. 09/30/20120
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations