The Recall Desk
HighFDA (Drugs)·D-0857-2023·Announced 2023-06-07

Amantadine Hydrochloride Oral Solution Recalled Due to CGMP Deviations

Akorn, Inc. is recalling all lots of Amantadine Hydrochloride Oral Solution (50mg/5mL) nationwide due to inability to complete required stability studies following the firm's closure, resulting in manufacturing quality deviations.

What this means for you

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: This is an FDA Class II recall involving a prescription drug with manufacturing quality deviations (CGMP non-compliance). However, no illnesses or injuries have been reported in the source text, and the specific nature of the stability concern is not detailed. The hazard is theoretical rather than demonstrated, placing this at the High level rather than Severe.

Plain-English summary

Akorn, Inc. is recalling all lots of Amantadine Hydrochloride Oral Solution USP, 50mg/5mL in 473mL bottles distributed nationwide in the United States and Puerto Rico. The recall was initiated because the firm went out of business and could no longer continue the stability studies required to maintain Current Good Manufacturing Practice (CGMP) compliance.

Amantadine Hydrochloride is a prescription antiviral medication. The inability to complete stability studies creates uncertainty about whether the product continues to meet quality and safety standards for its intended use.

Affected consumers who have this medication should contact their prescribing healthcare provider or pharmacist for guidance. Do not discontinue use of the medication without consulting your healthcare provider, as abrupt discontinuation may affect your health condition. Your pharmacist or physician can provide alternative medications or advice on proper disposal.

The recalled product

Product
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Antiviral Oral Solution
Hazard

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)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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