Drug product
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
D-1178-2022
Product summary
- Event
- Event 89863
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,058
- Official record key
drug-enforcement:D-1178-2022
Official wording
Reason: CGMP Deviations
Code information: Lot: GS029041, GS029353, GS02986, 5 mg; 90 tablets, Exp.: 09/2022; Lot: GS030056, GS030869, GS033943, Exp.: 10/2022; Lots: GS034490, GS035197, Exp.:02/2023; Lots: GS035198, Exp.: 03/2023; Lots: GS035596, GS035947, GS036759, GS037400, Exp.: 06/2023; Lots: GS038089, GS038763, GS039559, GS040150, Exp.: 10/2023; Lots: GS040151, GS040708, GS041107, Exp.: 12/2023; Lot: GS041654, Exp.: 03/2024.
Distribution pattern: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Derived failure modes
-
Manufacturing or process control
CGMP Deviations