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.
What this means for you
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
- manufacturing-defect
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.
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