D-1081-2019 Class II Terminated
FDA drug recall D-1081-2019 was initiated by RemedyRepack Inc. on March 14, 2019 and is designated Class II. Reason for recall: CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). The recall status is terminated (terminated April 11, 2019). Affected quantity: 33 blister cards of 30 = 990 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 14, 2019
- Termination Date
- April 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 blister cards of 30 = 990 tablets
Product Description
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).
Distribution Pattern
Product was distributed to one sole customer, Miami, FL.
Code Information
70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019