Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

FDA recall notice · announced June 1, 2022 · Remedyrepack

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Notes

Distribution: Recalled product was distributed to Florida.
Lot/code information: Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
Quantity: 22 bottles/90 count each
Status: Terminated
Products in this recall event:
- Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00 (D-0885-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.