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Recall Observatory FDA recall evidence

Drug product

Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

D-1179-2022

March 16, 2022

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 89863
Status
Ongoing
Classification
Class II
Quantity
31,260 bottles
Official record key
drug-enforcement:D-1179-2022

Official wording

Reason: CGMP Deviations

Code information: Lots: GS027890, GS028177, GS028488, 10 mg; 90 tablets, Exp.: 04/2022; Lots: GS028847, GS028848, Exp.: 09/2022; GS029627, GS029862,GS030057, GS030481, GS030870, GS031060, GS031437, GS031438, GS033527, GS034231, Exp.: 10/2022; Lots: GS034810, Exp.: 01/2023; Lots: GS035240, GS035598, Exp.: 05/2023; Lots: GS036194, Exp.: 06/2023; Lots: GS036760, GS036981,GS037526, GS038177, GS038728, Exp.: 08/2023; Lots: GS038729, GS041108, Exp.: 09/2023; Lots: GS039412, GS039840, GS041109, Exp.: 12/2023; Lot: GS041655, Exp.: 01/2024; Lot: GS041656, Exp.: 05/2024. (NDC: 60429-185-90).

Distribution pattern: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations