Losartan Potassium Tablets USP 50 mg 90 film coated recall: Impurity Out of Spec
Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO…
Why was Losartan Potassium Tablets USP 50 mg 90 film coated 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?
Lot CLO17009B exp 11/2019 Lot CLO17010A exp 11/2019 Lot CLO18023A exp 04/2020
- Product
- Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO…
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Quantity
- 34403 bottles
- Distribution
- Nationwide
- Recall date
- May 29, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)