FDAFDA · Food and drugs·Recall number D-343-2014
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
Published December 18, 2013 · Recall initiated: March 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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