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Recall Observatory FDA recall evidence

Drug product

Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01

D-1589-2014

July 01, 2014

Class I

Product summary

Firm
American Health Packaging
Event
Event 68779
Status
Terminated
Classification
Class I
Quantity
137,300 tablets
Official record key
drug-enforcement:D-1589-2014

Official wording

Reason: Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544

Code information: Lot #142588, Exp 01/2016

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up