Recalls / Class II
Class IID-1238-2020
Product
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
- Affected lot / code info
- Lot Code: GS018406, Exp. Date 6/30/2020; GS018858, Exp. Date 7/31/2020; GS019108, Exp. Date 7/31/2020; GS018521, Exp. Date 7/31/2020; GS018605, Exp. Date 7/31/2020; GS018911, Exp. Date 7/31/2020
Why it was recalled
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-04-03
- FDA classified
- 2020-04-13
- Posted by FDA
- 2020-04-22
- Terminated
- 2020-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1238-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.