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Class II: temporary or reversible health riskTerminated

RemedyRepack Losartan HCTZ 50/12 Recall

Losartan HCTZ 50/12

RemedyRepack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
Jun 1, 2022
Recall ID
D-0885-2022
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Summary

RemedyRepack recalled Losartan HCTZ 50/12 starting May 4, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0885-2022 on Jun 1, 2022. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Recalled product was distributed to Florida.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0885-2022
Classification
Class II
Status
Terminated
Recall initiated
May 4, 2022
FDA report date
Jun 1, 2022
Quantity
22 bottles/90 count each
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-0885-2022, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Terminated
Country
United States
Event ID
90134
Address
625 Kolter Dr Ste 4
Code information
Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
Postal code
15701-3571
Report date
Jun 1, 2022
Product type
Drugs
Recall number
D-0885-2022
Classification
Class II
Recalling firm
RemedyRepack Inc.
Product quantity
22 bottles/90 count each
Termination date
Sep 2, 2022
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Voluntary / mandated
Voluntary: Firm initiated
Product description
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Distribution pattern
Recalled product was distributed to Florida.
Recall initiation date
May 4, 2022
Initial firm notification
Letter
Center classification date
May 20, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0885-2022, published Jun 1, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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