Drug product
Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
D-0516-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6000 g
- Official record key
drug-enforcement:D-0516-2018
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) 080315-1, Exp. 04/05/2018; b) 080315-1, Exp. 04/05/2018, c) 080315-1, Exp. 04/05/2018.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations