Recall archive / FDA drug enforcement
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00 — FDA record D-0885-2022
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 4, 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 HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 22 bottles/90 count each
- Agency-reported status
- Terminated
- Source record identifier
- D-0885-2022
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 | Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Recalled product was distributed to Florida.
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 4, 2022
- Center classification date
- May 20, 2022
- Termination date
- Sep 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.