FDA Recall D-1589-2014
American Health Packaging · Columbus, OH
Class I — life-threatening Terminated 398 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
Reason for recall
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Recall record
- Recall number
D-1589-2014- 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 and Puerto Rico
- Recall initiated
- 2014-07-01
- Classified by FDA Center
- 2014-09-18
- FDA published
- 2014-09-24
- Terminated
- 2015-08-03
- Recalling firm
- American Health Packaging
- Firm location
- Columbus, OH