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
FDA recall notice · announced June 1, 2022 · Direct Rx
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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 .
Notes
Distribution: FL
Lot/code information: Lot: 25OC2116 Exp. 5/31/23
Quantity: 11 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0894-2022)
- Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 (D-0895-2022)
- 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 (D-0893-2022)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.