Entacapone Tablets Recalled for Failed Dissolution Specifications
The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.
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: This is an FDA Class II recall involving a manufacturing/quality defect (failed dissolution specifications) with no reported illnesses or injuries documented in the source. The hazard is product quality/efficacy-related rather than safety-threatening, warranting a Moderate classification.
Plain-English summary
The Harvard Drug Group is recalling Entacapone Tablets, USP, 200 mg (an oral prescription drug used as a catechol-O-methyltransferase inhibitor) due to failed dissolution specifications. The affected product consists of 1,632 cartons distributed by Major Pharmaceuticals to Colorado, Florida, Missouri, and Ohio.
The recall involves four lots with the following expiration dates: Lot N00187 (05/2022), Lot N00245 (06/2022), Lot N00273 (07/2022), and Lot N00355 (11/2022). All units carry NDC 0904-6822-04.
Dissolution specification failures may compromise the drug's bioavailability and therapeutic effect, meaning affected tablets may not release the active ingredient properly for absorption. Patients currently taking affected lots should consult their healthcare provider or pharmacist immediately about whether their medication may be affected and what steps to take.
The recalled product
- Product
- ENTACAPONE (ENTACAPONE)
- Brand
- ENTACAPONE
- Manufacturer
- The Harvard Drug Group
- Affected units
- 1,632
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 (9)
- Lot
- expiry: N00187
- 05/2022
- N00245
- 06/2022
- N00273
- 07/2022
- N00355
- 11/2022
Distribution
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