Losartan Potassium Tablets USP 100 mg 90 count bottle recall: Impurity Out of Spec
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Why was Losartan Potassium Tablets USP 100 mg 90 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?
GS014045,exp 06/2019, GS014305 exp 06/2019, GS014044 exp 0/2019, GS016535 exp 01/2020, GS016524 exp 01/2020, GS017384 exp 02/2020, GS017385 exp 01/2020, GS017539 exp 01/2020, GS017540 exp 01/2020, GS017543 exp 01/2020, GS017542 exp 01/2020 GS017984 exp 02/2020, GS017985 exp 02/2020, GS017986 exp 02/2020, GS018263 exp 02/2020, GS018264 exp 02/2020, GS018265 exp 02/2020
- Product
- Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 138,213 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)