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".
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
Lot numbers, UPCs & expiration codes
Lot #: 113032A, 113032B, Exp 04/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1645-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 25, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 1,170 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1645-2012, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 62792
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 113032A, 113032B, Exp 04/13
- Postal code
- 43217-1188
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1645-2012
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 1,170 cartons
- Termination date
- Jul 2, 2013
- 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".
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 25, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2012