The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0835-2023·Announced 2023-06-07

FDA Recalls Pilocarpine Ophthalmic Solution Due to Incomplete Stability Studies

Akorn Inc. recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 1% nationwide due to CGMP deviations. The firm went out of business and could not 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: This is a Class II recall for a prescription ophthalmic medication with unverified long-term stability due to incomplete testing. While no illnesses or injuries have been reported, the product represents a potential risk of harm because its safety and efficacy over its shelf life cannot be assured. This meets the criterion for a High severity recall as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Akorn, Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles distributed nationwide in the USA and Puerto Rico. This is a Class II recall.

The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the firm went out of business and could no longer continue the stability studies required to verify that the product remains safe and effective throughout its shelf life. Without completion of these stability studies, the product's long-term safety and efficacy cannot be assured.

The recalled product

Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
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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