Oxcarbazepine Tablets recall: Subpotent
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
Why was Oxcarbazepine Tablets recalled?
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
- Product
- 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
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Quantity
- 8,550 cartons and bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- December 18, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)