D-1238-2020 Class II Terminated
FDA drug recall D-1238-2020 was initiated by Golden State Medical Supply Inc. on April 3, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products. The recall status is terminated (terminated October 8, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- April 22, 2020
- Initiation Date
- April 3, 2020
- Termination Date
- October 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Distribution Pattern
Nationwide
Code Information
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