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Recall Observatory FDA recall evidence

Drug product

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

D-1683-2012

September 04, 2012

Class III

Product summary

Firm
Apace KY LLC
Event
Event 63080
Status
Terminated
Classification
Class III
Quantity
81,516 bottles
Official record key
drug-enforcement:D-1683-2012

Official wording

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

Code information: Lot: DL11600 Exp Date: 06/13

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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