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Recall Observatory FDA recall evidence

Drug product

ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.

D-919-2013

June 17, 2013

Class I

Product summary

Firm
Advance Pharmaceutical Inc
Event
Event 65484
Status
Terminated
Classification
Class I
Quantity
16,440 bottles
Official record key
drug-enforcement:D-919-2013

Official wording

Reason: Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.

Code information: Lot #: 13A026, Exp 01/15

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up