Key Takeaway

Losartan 50mg Tablet, 30 count each blister card. by RemedyRepack Inc. was recalled on March 14, 2019. The hazard: CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid...

FDA Drug Class II Terminated

Losartan 50mg Tablet, 30 count each blister card.

Recalled: March 14, 2019 ~33 blister cards of 30 = 990 tablets units affected D-1081-2019

Description

Losartan 50mg Tablet, 30 count each blister card.

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Losartan 50mg Tablet, 30 count each blister card.

Drugs

Company Information

RemedyRepack Inc.

Indiana, PA, United States

View all 61 recalls by RemedyRepack Inc. →

Distribution

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

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.