Drug product
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
D-0112-2021
Product summary
- Event
- Event 86786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,922 bottles
- Official record key
drug-enforcement:D-0112-2021
Official wording
Reason: FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Code information: Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out-of-specification