Drug product
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
D-1180-2022
Product summary
- Event
- Event 89863
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,424 bottles
- Official record key
drug-enforcement:D-1180-2022
Official wording
Reason: CGMP Deviations
Code information: Lots: GS035031, GS035199, 20 mg; 90 tablets, Exp.: 03/2022; Lots: GS036495, GS036904, Exp.: 05/2022; Lots: GS037401, Exp.: 09/2022; Lots: GS037986, GS038359, GS039560, Exp.: 11/2022; Lot: GS041110, Exp.: 12/2022. (NDC: 60429-186-90).
Distribution pattern: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Derived failure modes
-
Manufacturing or process control
CGMP Deviations