D-919-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 4, 2013
- Initiation Date
- June 17, 2013
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,440 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 13A026, Exp 01/15