Losartan Potassium Tablets USP 100 mg 1000 count bottle recall: Impurity Out of Spec
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
Why was Losartan Potassium Tablets USP 100 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?
GS014054 exp 06/2019, GS016338 exp 12/2019, GS016341 exp 01/2020, GS016342 exp 01/2020, GS016343 exp 01/2020, GS016344 exp 01/2020, GS016345 exp 01/2020, GS016539 exp 01/2020, GS016969 exp 01/2020, GS016973 exp 01/2020, GS017337 exp 01/2020, GS018524 exp 02/2020
- Product
- Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 8,767 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)