FDA recall D-919-2013

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.

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

Nationwide

Key facts

Status

Terminated

Initiation date

2013-06-17

Report date

2013-09-04

Termination date

2016-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Holtsville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-919-2013