Key Takeaway

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 by Apace KY LLC was recalled on September 4, 2012. The hazard: Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

FDA Drug Class III Terminated

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

Recalled: September 4, 2012 ~81,516 bottles units affected D-1683-2012

Description

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

Hazard / Reason

Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

Drugs

Company Information

Apace KY LLC

Fountain Run, KY, United States

View all 5 recalls by Apace KY LLC →

Distribution

Nationwide

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Frequently Asked Questions

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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?

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