Recalls / Class II
Class IID-1177-2022
Product
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.
- 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: GS028301, 2.5 mg; 90 tablets, Exp.: 06/2022; Lots: GS029973, GS029974, GS031436, GS031715, GS033191, GS033940, Exp. : 10/2022; Lot: GS034212, Exp.: 12/2022; Lot: GS035315, GS035945, GS036905, GS038038, GS039199, Exp.: 04/2023; Lot: GS039200, GS040149, Exp.: 11/2023. (NDC: 60429-183-90).
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
- 1,471 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-1177-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.