The Recall Desk
HighFDA (Drugs)·D-0885-2022·Announced 2022-06-01

Losartan HCTZ Medication Recalled for Elevated AZIDO Impurity

RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.

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: FDA Class II recall with no reported illnesses or injuries. The hazard involves elevated AZIDO impurity levels in a pharmaceutical product exceeding acceptable manufacturing standards, representing a documented risk of harm even though no actual injury has been reported. This meets the criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets in 90-count bottles. The recall affects 22 bottles with lot numbers B1377711-100521 and B1412137-102621, both expiring October 31, 2022. The original product NDC is 33342-0050-10, and the repackaged product NDC is 70518-3231-00.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, with AZIDO impurity levels detected above acceptable limits in the affected batches.

The recalled product was distributed to Florida.

The recalled product

Product
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Manufacturer
RemedyRepack Inc.
Category
Drug
Hazard
  • azido-impurity

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 (3)

  • Lot # B1377711-100521
  • exp. date 10/31/2022 B1412137-102621
  • exp. date 10/31/2022

Distribution

Distribution scope not specified by the agency.

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