Amantadine hydrochloride capsules recalled after failing dissolution specifications
AvKARE is recalling one lot of Amantadine HCl 100 mg capsules after an out-of-specification finding in dissolution testing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a prescription medicine that may not release its dose as specified, with no injuries stated in the source.
Plain-English summary
AvKARE is recalling Amantadine HCl Capsules USP, 100 mg, in 50-capsule (5 x 10) unit dose packs, prescription only, NDC 50268-069-15. The product was distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated due to an out-of-specification finding in dissolution, meaning the product failed dissolution specifications.
Affected product is lot 49261, with an expiry date of 04/30/27.
Patients and pharmacies can identify affected product by the NDC, lot number and expiry date above, and may contact AvKARE for further information.
The recalled product
- Product
- AMANTADINE HCL (AMANTADINE HYDROCHLORIDE)
- Brand
- AMANTADINE HCL
- Manufacturer
- AvKARE
- Category
- Drug — Prescription capsule
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 # 49261
- Exp: 04/30/27
Distribution
Distributed nationwide across the United States.
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