Losartan Potassium Tablets USP 25 mg 1000 count bottle recall: Impurity Out of Spec
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
Why was Losartan Potassium Tablets USP 25 mg 1000 count bottle recalled?
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
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?
GS015204 exp 06/ 2019, GS018318 exp 02/2020, GS014817 exp 06/2019, GS017342 exp 02/2020, GS017808 exp 02/2020
- Product
- Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 11,286 HDPE Bottles
- Distribution
- IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
- Recall date
- May 29, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)