Why it was recalled
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Product description
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
Lot numbers, UPCs & expiration codes
Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
Where it was sold
Nationwide and Puerto Rico
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-343-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 18, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 8,550 cartons and bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Roxane Inc
Original FDA data
Every field from FDA enforcement report D-343-2014, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 66288
- Address
- 1809 Wilson Rd
- Code information
- Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
- Postal code
- 43228-9579
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-343-2014
- Classification
- Class III
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Product quantity
- 8,550 cartons and bottles
- Termination date
- Feb 12, 2014
- Reason for recall
- SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 11, 2013