Recall archive / FDA drug enforcement
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09 — FDA record D-0887-2022
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 2, 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 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 30 bottles/90 count = 2,700 tablets
- Agency-reported status
- Terminated
- Source record identifier
- D-0887-2022
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 # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to FL, SC and VA
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 2, 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.