Class II
Terminated
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
This recall has been terminated (originally issued June 1, 2022).
- Company
- Direct Rx
- Recall Initiated
- May 11, 2022
- Posted
- June 1, 2022
- Recall Number
- D-0894-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6 bottles
- Firm Location
- Dawsonville, GA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Distribution
FL
Lot / Code Info
Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25
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