Recalls / Class II
Class IID-1179-2022
Product
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
- Brand name
- Enalapril Maleate
- Generic name
- Enalapril Maleate
- Active ingredient
- Enalapril Maleate
- Route
- Oral
- NDCs
- 60429-183, 60429-184, 60429-185, 60429-186
- FDA application
- ANDA075657
- Affected lot / code info
- 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).
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 31,260 bottles
- Distribution pattern
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Timeline
- Recall initiated
- 2022-03-16
- FDA classified
- 2022-07-07
- Posted by FDA
- 2022-07-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1179-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.