Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Reported: June 8, 2022 Initiated: May 5, 2022 #D-0971-2022
Product Description
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 81 bottles
- Distribution
- AL, GA, FL, LA
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90. Recalled by Direct Rx. Units affected: 81 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 8, 2022. Severity: Moderate. Recall number: D-0971-2022.
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