Drug product
Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
D-0476-2018
Product summary
- Event
- Event 79149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55500 g
- Official record key
drug-enforcement:D-0476-2018
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) 021816-2, 021816-3, Exp. 08/24/2018; 70616-1, Exp. 01/31/2019; b) 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019; c) 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019; d) 021816-1, Exp. 08/24/2018; 070616-1, exp. 01/31/2019.
Distribution pattern: Nationwide within USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations