PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: September 24, 2014 Initiated: July 1, 2014 #D-1589-2014

Product Description

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

Details

Recalling Firm
American Health Packaging
Units Affected
137,300 tablets
Distribution
Nationwide and Puerto Rico
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by American Health Packaging. Units affected: 137,300 tablets.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Drug on September 24, 2014. Severity: Critical. Recall number: D-1589-2014.