Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Reported: October 7, 2020 Initiated: March 12, 2019 #D-0032-2021
Product Description
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Reason for Recall
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 33 bottles
- Distribution
- FL
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90. Recalled by Direct Rx. Units affected: 33 bottles.
Why was this product recalled? ▼
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 7, 2020. Severity: Moderate. Recall number: D-0032-2021.
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