Drug product
Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
D-0475-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 684 g
- Official record key
drug-enforcement:D-0475-2018
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) 011116-1, Exp. 07/31/2020; b) 011116-1, 011116-2, Exp. 07/31/2020; c) 011116-1, Exp. 07/31/2020
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations