The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0863-2023·Announced 2023-06-07

Ropivacaine Hydrochloride Injection recalled; manufacturer unable to complete stability studies

Akorn, Inc. recalls all lots of Ropivacaine Hydrochloride Injection nationwide because the manufacturer went out of business and cannot complete required stability studies.

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: FDA Class II recall of an injectable drug with unverified stability. Although no illnesses or injuries have been reported, an injectable medication where the manufacturer cannot complete required stability studies to verify safety and effectiveness represents a risk-of-harm situation justifying High severity.

Plain-English summary

Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.2%, an injectable pharmaceutical supplied in 100 mL vials.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required by the FDA. These studies are necessary to verify that the product maintains its safety and effectiveness throughout its shelf life.

The affected product was distributed nationwide in the United States and Puerto Rico, and all manufacturing lots are included in the recall.

The recalled product

Product
Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable Drug
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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