Drug product

Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311

D-1645-2012

July 25, 2012

Class III

Product summary

Firm: American Health Packaging
Event: Event 62792
Status: Terminated
Classification: Class III
Quantity: 1,170 cartons
Official record key: drug-enforcement:D-1645-2012

Official wording

Reason: Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".

Code information: Lot #: 113032A, 113032B, Exp 04/13

Distribution pattern: Nationwide

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

Labeling: Label Mix-Up: A typographical error