Reported Sep 4, 2013 · Terminated

ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth,…

Advance Pharmaceutical Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advance Pharmaceutical Inc · 895 Waverly Avenue · Holtsville, NY · 11742

Is this the product you have?

    • ENTERIC COATED ASPIRIN (NSAID)
    • 81 mg
    • 120-count tablets per bottle
  • distributed byRugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9
Lot codes and dates
    • Lot #: 13A026
    • Exp 01/15
Amount recalled
16,440 bottles

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 19, 2016 · Data as of Sep 19, 7:15 PM UTC

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