RemedyRepack Recalls Carbamazepine 200 mg Tablets Due to Dissolution Failure
RemedyRepack Inc. is recalling Carbamazepine 200 mg tablets because routine stability testing revealed low dissolution results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 II, and the hazard involves a failed dissolution specification without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
RemedyRepack Inc. is recalling Carbamazepine 200 mg Tablets, 100-unit dose tablets per box. The product is prescription-only and was repackaged by RemedyRepack Inc. in Indiana, PA. The specific lot affected is B0796217-020920 with an expiration date of 02/28/2021.
The recall was initiated because low out-of-specification (OOS) dissolution results were obtained during routine stability testing. This indicates that the tablets may not dissolve at the required rate, which could affect the medication's performance.
The product was distributed to Minnesota. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 498
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 #: B0796217-020920
- Exp. Date: 02/28/2021
Distribution
Distributed in 1 state:
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