Losartan 50mg Tablet recall: Impurity Out of Spec
Losartan 50mg Tablet, 30 count each blister card.
Why was Losartan 50mg Tablet recalled?
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
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?
70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019
- Product
- Losartan 50mg Tablet, 30 count each blister card.
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 33 blister cards of 30 = 990 tablets
- Distribution
- Product was distributed to one sole customer, Miami, FL.
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)