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Class II: temporary or reversible health riskTerminated

RemedyRepack Losartan 50mg Tablet Recall

Losartan 50mg Tablet, 30 count each blister card

RemedyRepack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
Apr 17, 2019
Recall ID
D-1081-2019
Check your lot numberHow we source this data

Summary

RemedyRepack recalled Losartan 50mg Tablet starting Mar 14, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1081-2019 on Apr 17, 2019. Reason: CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). Status: Terminated.

Why it was recalled

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Product description

Losartan 50mg Tablet, 30 count each blister card.

Lot numbers, UPCs & expiration codes

70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019

Where it was sold

Product was distributed to one sole customer, Miami, FL.

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-1081-2019
Classification
Class II
Status
Terminated
Recall initiated
Mar 14, 2019
FDA report date
Apr 17, 2019
Quantity
33 blister cards of 30 = 990 tablets
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-1081-2019, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Terminated
Country
United States
Event ID
82532
Address
625 Kolter Dr Ste 4
Code information
70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019
Postal code
15701-3571
Report date
Apr 17, 2019
Product type
Drugs
Recall number
D-1081-2019
Classification
Class II
Recalling firm
RemedyRepack Inc.
Product quantity
33 blister cards of 30 = 990 tablets
Termination date
Apr 11, 2019
Reason for recall
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Voluntary / mandated
Voluntary: Firm initiated
Product description
Losartan 50mg Tablet, 30 count each blister card.
Distribution pattern
Product was distributed to one sole customer, Miami, FL.
Recall initiation date
Mar 14, 2019
Initial firm notification
Letter
Center classification date
Apr 5, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1081-2019, published Apr 17, 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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