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Class II: temporary or reversible health riskOngoing

Avkare Losartan Potassium Tablets 25 mg 50 tablets Recall

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-…

AVKARE Inc. · Pulaski, TN

Risk level
Class II
Reported by FDA
May 8, 2019
Recall ID
D-1250-2019
Check your lot numberHow we source this data

Summary

Avkare recalled Losartan Potassium Tablets 25 mg 50 tablets starting Apr 24, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1250-2019 on May 8, 2019. 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 of 0.96 parts per million. Status: Ongoing.

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 of 0.96 parts per million.

Product description

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

Lot numbers, UPCs & expiration codes

Lot: 19554 Exp. 4/30/2019

Where it was sold

Nationwide

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-1250-2019
Classification
Class II
Status
Ongoing
Recall initiated
Apr 24, 2019
FDA report date
May 8, 2019
Quantity
846 cartons (42,300 tablets)
Recall type
Voluntary: Firm initiated
Recalling firm
AVKARE Inc.

Original FDA data

Every field from FDA enforcement report D-1250-2019, exactly as published.

Show all FDA fields
City
Pulaski
State
TN
Status
Ongoing
Country
United States
Event ID
82706
Address
615 N 1st St
Code information
Lot: 19554 Exp. 4/30/2019
Postal code
38478-2403
Report date
May 8, 2019
Product type
Drugs
Recall number
D-1250-2019
Classification
Class II
Recalling firm
AVKARE Inc.
Product quantity
846 cartons (42,300 tablets)
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 of 0.96 parts per million.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Distribution pattern
Nationwide
Recall initiation date
Apr 24, 2019
Initial firm notification
Letter
Center classification date
Apr 28, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1250-2019, published May 8, 2019. 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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