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
Reported: December 18, 2013 Initiated: March 18, 2013 #D-343-2014
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
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.
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- 8,550 cartons and bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 8,550 cartons and bottles.
Why was this product recalled? ▼
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2013. Severity: Low. Recall number: D-343-2014.
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