Class II
Terminated
Losartan 50mg Tablet, 30 count each blister card.
- Company
- Remedyrepack Inc.
- Recall Initiated
- March 14, 2019
- Posted
- April 17, 2019
- Recall Number
- D-1081-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 33 blister cards of 30 = 990 tablets
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Distribution
Product was distributed to one sole customer, Miami, FL.
Lot / Code Info
70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019
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