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Class II: temporary or reversible health riskTerminated

Direct Rx Losartan Potassium 100 mg Recall

Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Dire…

Direct Rx · Dawsonville, GA

Risk level
Class II
Reported by FDA
Oct 14, 2020
Recall ID
D-0018-2021
Check your lot numberHow we source this data

Summary

Direct Rx recalled Losartan Potassium 100 mg starting Apr 30, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0018-2021 on Oct 14, 2020. Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer. Status: Terminated.

Why it was recalled

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer

Product description

Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30

Lot numbers, UPCs & expiration codes

Lot: 27AU1801 Exp. 02/28/2021

Where it was sold

GA

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-0018-2021
Classification
Class II
Status
Terminated
Recall initiated
Apr 30, 2019
FDA report date
Oct 14, 2020
Quantity
33 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Direct Rx

Original FDA data

Every field from FDA enforcement report D-0018-2021, exactly as published.

Show all FDA fields
City
Dawsonville
State
GA
Status
Terminated
Country
United States
Event ID
86499
Address
94 Worldwide Dr
Code information
Lot: 27AU1801 Exp. 02/28/2021
Postal code
30534-6828
Report date
Oct 14, 2020
Product type
Drugs
Recall number
D-0018-2021
Classification
Class II
Recalling firm
Direct Rx
Product quantity
33 bottles
Termination date
Dec 4, 2020
Reason for recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Voluntary / mandated
Voluntary: Firm initiated
Product description
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Distribution pattern
GA
Recall initiation date
Apr 30, 2019
Initial firm notification
Letter
Center classification date
Oct 5, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0018-2021, published Oct 14, 2020. 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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