Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications
The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.
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: This is an FDA Class II recall involving a quality defect (failed dissolution specifications) with no reported illnesses or injuries. The hazard is a reduced therapeutic effect rather than direct patient harm, placing it in the Moderate category per the severity rubric.
Plain-English summary
The Harvard Drug Group is recalling Carbamazepine 200mg Tablets, USP (NDC 0904-6172-61) distributed under Lot R01562 with an expiration date of 10/2022. The recall affects 4 cartons of 100-count unit dose packages manufactured by Torrent Pharmaceuticals Ltd. in India and distributed to North Carolina.
The tablets failed to meet dissolution specifications, which are critical quality standards that ensure the medication dissolves and becomes bioavailable in the body as intended. Carbamazepine is a prescription mood stabilizer and anticonvulsant used to treat seizures, nerve pain, and bipolar disorder. If dissolution is compromised, patients may not receive the full therapeutic benefit of their medication.
Patients currently taking this lot of carbamazepine should contact their healthcare provider or pharmacist to determine whether they have received affected tablets and to discuss next steps. Do not stop taking carbamazepine without medical guidance, as abrupt discontinuation can cause serious adverse effects. Healthcare providers and patients should verify their lot numbers against the recall information provided by the FDA.
The recalled product
- Product
- CARBAMAZEPINE (CARBAMAZEPINE)
- Brand
- CARBAMAZEPINE
- Manufacturer
- The Harvard Drug Group
- Hazard
- dissolution-failure
- reduced-efficacy
- quality-defect
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 (2)
- Lot R01562
- Exp. 10/2022
Distribution
Distributed in 1 state:
- NC
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