Oxcarbazepine Tablets Recalled for Potential Subpotency
Boehringer Ingelheim Roxane Inc. is recalling Oxcarbazepine Tablets, 150 mg, due to out-of-specification assay results and potential lower weight tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, aligning with the Moderate severity score for minor labeling or specification errors without reported illness.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is recalling Oxcarbazepine Tablets, 150 mg, in 10 x 10 count unit-dose blisters (NDC 0054-0097-20) and 100-count bottles (NDC 0054-0097-25). The recall involves 8,550 cartons and bottles distributed nationwide and in Puerto Rico.
The firm discovered out-of-specification results for assay, and an extended investigation revealed the potential for lower weight tablets. This condition is classified as a subpotent drug issue. The affected lots are 259666A and 259666B, both with an expiration date of March 2014.
Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If found, the product should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- 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
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 8,550
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) 259666A
- Exp. MAR 2014
- b) 259666B
Distribution
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