Recalls / Class II
Class IID-1081-2019
Product
Losartan 50mg Tablet, 30 count each blister card.
- Affected lot / code info
- 70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019
Why it was recalled
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 33 blister cards of 30 = 990 tablets
- Distribution pattern
- Product was distributed to one sole customer, Miami, FL.
Timeline
- Recall initiated
- 2019-03-14
- FDA classified
- 2019-04-05
- Posted by FDA
- 2019-04-17
- Terminated
- 2019-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1081-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.