Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09

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 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09

Reason for recall

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

Notes

Distribution: Product was distributed to FL, SC and VA
Lot/code information: Lot # B1329507-082921, exp. date 08/31/2022 B1348363-091421, exp. date 09/30/2022 B1387286-101021, exp. date 10/31/2022 B1390974-101221, exp. date 10/31/2022 B1426010-110521, exp. date 11/30/2022
Quantity: 26/90 count bottles = 2,340 tablets
Status: Terminated
Products in this recall event:
- Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09 (D-0887-2022)
- Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09 (D-0886-2022)

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