FDA-Drug2013-09-04Class I
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.
Advance Pharmaceutical Inc
Hazard
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.
Sold states
Nationwide
Affected count
16,440 bottles
Manufactured in
895 Waverly Avenue, Holtsville, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-919-2013Don't want to check this manually?
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