The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0137-2023·Announced 2023-01-25

FDA Recalls Cromolyn Sodium Eye Drops Nationwide for Manufacturing Defects

Akorn, Inc. is recalling 188,550 bottles of Cromolyn Sodium Ophthalmic Solution nationwide due to manufacturing quality control deviations.

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: This is an FDA Class II voluntary recall with no reported illnesses or injuries. The recall is classified as a voluntary precautionary measure due to manufacturing quality control deviations, fitting the Moderate severity criterion for voluntary precautionary recalls.

Plain-English summary

Akorn, Inc. is recalling Cromolyn Sodium Ophthalmic Solution, USP 4%, in 10mL bottles (NDC 17478-291-11). Approximately 188,550 bottles have been recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations. Affected lot numbers include 0G75A, 0G12A, 0H50A, 0J88A, 1D98A, 1E31A, 1D97A, and 1H14A, with expiration dates ranging from June 2023 to July 2024.

Patients currently using this medication should contact their healthcare provider or pharmacist before discontinuing use. Medical guidance should be sought to determine the appropriate course of action.

The recalled product

Product
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
188,550

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 (14)

  • Lot: 0G75A
  • 0G12A
  • EXP 6/30/2023
  • 0H50A
  • EXP 7/31/2023
  • 0J88A
  • EXP 8/31/2023
  • 1D98A
  • EXP 3/31/2024
  • 1E31A
  • EXP 4/30/2024
  • 1D97A
  • 1H14A
  • EXP 7/31/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

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