Drug product
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
D-0594-2018
Product summary
- Event
- Event 78809
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3000 bottles
- Official record key
drug-enforcement:D-0594-2018
Official wording
Reason: CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Code information: Lot #: ARI17089, ARI17090, Exp. 5/2019
Distribution pattern: NJ Only
Derived failure modes
-
Manufacturing or process control
CGMP Deviations