Losartan Potassium Tablets recall: Impurity Out of Spec
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…
Why was Losartan Potassium Tablets recalled?
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Golden State Medical Supply Inc.
- Distribution
- Nationwide
- Recall date
- April 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)