Drug product
Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
D-0526-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 611400 g
- Official record key
drug-enforcement:D-0526-2018
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) 032117A-6, Exp. 01/21/2019; 112916-2, 112916-4, Exp. 10/17/2018; b) 032117A-4, 032117A-5, Exp. 01/21/2019; 112916-1, Exp. 10/17/2018; 112916-4, Exp. 10/17/2018; c) 032117A-1, 032117A-2, 032117A-3, 032117A-4, 032117A-5, Exp. 01/21/2019; 112916-1, 112916-2, 112916-3, 112916-4, Exp. 10/17/2018.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations