The Recall Desk
HighFDA (Drugs)·D-0887-2022·Announced 2022-06-01

Losartan HCTZ tablets recalled for manufacturing impurity levels above acceptable limits

RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recall affects bottles distributed to Florida, South Carolina, and Virginia.

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, which indicates a serious quality issue. However, no illnesses, injuries, or deaths have been reported in connection with this recall. The manufacturing deviation resulting in elevated AZIDO impurity levels represents a potential risk of harm, warranting a High severity score per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets packaged in 90-count bottles (NDC 70518-2564-00) due to a manufacturing quality issue.

The recall was initiated because testing identified AZIDO impurity levels above acceptable limits in the affected product. This represents a deviation from current good manufacturing practices (CGMP).

The recalled product was distributed to patients in Florida, South Carolina, and Virginia. The affected lot numbers are B1364261-092721 (expiration 09/30/2022), B1377667-100521 (expiration 10/31/2022), B1412576-102621 (expiration 10/31/2022), and B1436925-111321 (expiration 11/30/2022).

Patients with this product should contact their pharmacy or healthcare provider for guidance regarding this recall.

The recalled product

Product
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Manufacturer
RemedyRepack Inc.
Category
Drug
Hazard

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 (5)

  • 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

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by RemedyRepack Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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