Carbamazepine Extended-Release Tablets Recalled for Failed Dissolution Specifications
American Health Packaging is recalling Carbamazepine Extended-Release Tablets, 400 mg, because they failed to meet dissolution specifications.
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 source text does not report any illnesses or injuries. The hazard is a failure to meet quality specifications (dissolution), which is a moderate risk of ineffective treatment rather than an immediate physical injury.
Plain-English summary
American Health Packaging is recalling Carbamazepine, Extended-Release Tablets, USP, 400 mg. The recall involves 457 cartons of the product, which are distributed nationwide in the United States. The specific lot number is 181677, with an expiration date of 11/30/2020. The NDC Carton number is 68084-562-21 and the NDC Unit Dose number is 68084-562-11.
The reason for the recall is that the tablets failed to meet dissolution specifications. Dissolution testing ensures that the medication releases the active ingredient at the correct rate and amount in the body. When these specifications are not met, the medication may not work as intended.
Patients and healthcare providers who have this specific lot of Carbamazepine should stop using it and contact their healthcare provider for guidance on alternative treatment options. The product is prescription-only, so consumers should not attempt to self-manage this recall without professional medical advice.
The recalled product
- Product
- Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
- Manufacturer
- American Health Packaging
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 457
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 181677
- exp 11/30/2020
Distribution
Distributed nationwide across the United States.
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