Recalls / Class I
Class ID-1590-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01
- Affected lot / code info
- Lot #142544, Exp 02/2016
Why it was recalled
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.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 59,200 tablets
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-07-01
- FDA classified
- 2014-09-18
- Posted by FDA
- 2014-09-24
- Terminated
- 2015-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1590-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.