Recalls / Class III
Class IIID-1645-2012
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
- Affected lot / code info
- Lot #: 113032A, 113032B, Exp 04/13
Why it was recalled
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".
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 1,170 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-07-25
- FDA classified
- 2012-08-14
- Posted by FDA
- 2012-08-22
- Terminated
- 2013-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1645-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.