FDA Recall D-919-2013
Advance Pharmaceutical Inc · Holtsville, NY
Class I — life-threatening Terminated 1067 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-919-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2013-06-17
- Classified by FDA Center
- 2013-08-23
- FDA published
- 2013-09-04
- Terminated
- 2016-05-19
- Recalling firm
- Advance Pharmaceutical Inc
- Firm location
- Holtsville, NY