FDA Recall D-1179-2022

Golden State Medical Supply Inc. · Camarillo, CA

Class II Ongoing 1520 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: 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).

Quantity: 31,260 bottles

Reason for recall

CGMP Deviations

Recall record

Recall number: D-1179-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Recall initiated: 2022-03-16
Classified by FDA Center: 2022-07-07
FDA published: 2022-07-13
Recalling firm: Golden State Medical Supply Inc.
Firm location: Camarillo, CA

Drug identification

Brand name(s): ENALAPRIL MALEATE
Generic name(s): ENALAPRIL MALEATE
Manufacturer(s): Golden State Medical Supply, Inc.
NDC(s): 60429-183, 60429-184, 60429-185, 60429-186
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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