Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Reported: June 1, 2022 Initiated: May 11, 2022 #D-0893-2022
Product Description
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 11 bottles
- Distribution
- FL
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540. Recalled by Direct Rx. Units affected: 11 bottles.
Why was this product recalled? ▼
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2022. Severity: Moderate. Recall number: D-0893-2022.
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