Losartan 50mg Tablet, 30 count each blister card.

FDA recall notice · announced April 17, 2019 · Remedyrepack

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Losartan 50mg Tablet, 30 count each blister card.

Reason for recall

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Notes

Distribution: Product was distributed to one sole customer, Miami, FL.
Lot/code information: 70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019
Quantity: 33 blister cards of 30 = 990 tablets
Status: Terminated
Products in this recall event:
- Losartan 50mg Tablet, 30 count each blister card. (D-1081-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.