Drug product
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.
D-1177-2022
Product summary
- Event
- Event 89863
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,471 bottles
- Official record key
drug-enforcement:D-1177-2022
Official wording
Reason: CGMP Deviations
Code information: Lots: GS028301, 2.5 mg; 90 tablets, Exp.: 06/2022; Lots: GS029973, GS029974, GS031436, GS031715, GS033191, GS033940, Exp. : 10/2022; Lot: GS034212, Exp.: 12/2022; Lot: GS035315, GS035945, GS036905, GS038038, GS039199, Exp.: 04/2023; Lot: GS039200, GS040149, Exp.: 11/2023. (NDC: 60429-183-90).
Distribution pattern: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Derived failure modes
-
Manufacturing or process control
CGMP Deviations