Recall archive / FDA drug enforcement
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceut... — FDA record D-0971-2022
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 5, 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 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
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Classification
- Class II
- Recalling firm
- Direct Rx
- Quantity
- 81 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0971-2022
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 | a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AL, GA, FL, LA
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 8, 2022
- Recall initiation date
- May 5, 2022
- Center classification date
- May 27, 2022
- Termination date
- Oct 5, 2023
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.