Losartan 50mg Tablet, 30 count each blister card.
Reported: April 17, 2019 Initiated: March 14, 2019 #D-1081-2019
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).
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 33 blister cards of 30 = 990 tablets
- Distribution
- Product was distributed to one sole customer, Miami, FL.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Losartan 50mg Tablet, 30 count each blister card.. Recalled by RemedyRepack Inc.. Units affected: 33 blister cards of 30 = 990 tablets.
Why was this product recalled? ▼
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Moderate. Recall number: D-1081-2019.
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