The Recall Desk
HighFDA (Drugs)·D-0886-2022·Announced 2022-06-01

Losartan HCTZ drug recall due to azido impurity levels above limits

RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is classified as FDA Class II. No hospitalizations or injuries are reported in the source. The hazard represents a manufacturing quality issue with pharmaceutical impurity exceeding acceptable limits, creating a risk-of-harm situation without reported illness.

Plain-English summary

RemedyRepack Inc. is recalling specific lots of Losartan HCTZ 100/25 mg tablets due to a manufacturing deviation. Testing detected azido impurity levels above acceptable limits.

The affected product was distributed in Florida, South Carolina, and Virginia. The recall involves four lot numbers with expiration dates between August and November 2022.

The recalled product

Product
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
Manufacturer
RemedyRepack Inc.
Category
Drug
Hazard
  • azido-impurity
  • cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distribution

Distributed in 3 states:

  • FL
  • SC
  • VA

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