Drug product
Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
D-0527-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47500 g
- Official record key
drug-enforcement:D-0527-2018
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) 042016-2, Exp. 4/6/2019; b) 041217-1, Exp. 02/09/2019; 042016-2, 042016-3, Exp. 4/6/2019; c) 041217-1, 041217-3, Exp. 02/09/2019; 042016-1, Exp. 04/06/2019; 042016-2, Exp. 4/6/2019; d) 041217-3, Exp. 01/09/2019; 042016-1, Exp. 4/6/2019.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations