Recall archive / FDA drug enforcement
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mf... — FDA record D-0894-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Classification
- Class II
- Recalling firm
- Direct Rx
- Quantity
- 6 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0894-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
FL
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 1, 2022
- Recall initiation date
- May 11, 2022
- Center classification date
- May 24, 2022
- Termination date
- Dec 2, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.