Drug Enforcement D-919-2013

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.

Status

Terminated

Classification

Class I

Report Date

September 4, 2013

Termination Date

May 19, 2016

Product Information

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.
Product quantity
16,440 bottles
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.
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Advance Pharmaceutical Inc
Address
895 Waverly Avenue

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-919-2013
Event ID
65484
Recall initiation date
June 17, 2013
Center classification date
August 23, 2013
Code info
Lot #: 13A026, Exp 01/15
More code info