AvKARE Recalls Amantadine HCl Capsules for Dissolution Failure
AvKARE Inc. is recalling 2,135 cartons of Amantadine HCl Capsules, 100 mg, because the product failed 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or mislabeling of a high-risk allergen or pathogen.
Plain-English summary
AvKARE Inc. is recalling 2,135 cartons of Amantadine HCl Capsules, USP, 100 mg. The affected product is identified by Lot 16719 with an expiration date of 07/2018. The recall was initiated because the product failed to meet dissolution specifications.
The recalled product is distributed nationwide. It is a prescription-only medication manufactured for AvKARE Inc. in Pulaski, TN. The specific NDC for the recalled unit is 50268-069-15.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- AMANTADINE HCL (AMANTADINE HYDROCHLORIDE)
- Brand
- AMANTADINE HCL
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,135
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 (1)
- Lot: 16719 Exp. 07/2018
Distribution
Distributed nationwide across the United States.
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