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
Product summary
- 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
Labeling: Label Mix-Up