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Recall Observatory FDA recall evidence

Drug product

Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20

D-882-2013

June 14, 2013

Class III

Product summary

Firm
Boehringer Ingelheim Roxane Inc
Event
Event 65467
Status
Terminated
Classification
Class III
Quantity
14,619 cartons
Official record key
drug-enforcement:D-882-2013

Official wording

Reason: Labeling: Missing Label; missing label on blister card

Code information: The affected product consists of lot #261739A, expiration date OCT 2014.

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing Label; missing