Status
Terminated
Drug Enforcement D-1645-2012
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".
Classification
Class III
Report Date
August 22, 2012
Termination Date
July 2, 2013
Product Information
- Product description
- 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
- Product quantity
- 1,170 cartons
- Reason for recall
- 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".
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- American Health Packaging
- Address
-
2550 John Glenn Ave Ste A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1645-2012
- Event ID
- 62792
- Recall initiation date
- July 25, 2012
- Center classification date
- August 14, 2012
- Code info
- Lot #: 113032A, 113032B, Exp 04/13
- More code info
- —