Akorn Recalls Proparacaine Hydrochloride Ophthalmic Solution Due to Chemical Contamination
Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution, 0.5%, due to chemical contamination from equipment cleaning residue.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
Akorn, Inc. is recalling 33,343 bottles of Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle. The product is sterile and prescription-only, manufactured by Akorn, Inc. in Lake Forest, IL. The specific lot affected is 9E52A with an expiration date of 04/2021.
The recall was initiated because out-of-specification results were obtained for equipment cleaning residue rinse samples, indicating chemical contamination. The product was distributed nationwide in the USA and Puerto Rico.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 33,343
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 (2)
- Lot 9E52A
- exp 04/2021
Distribution
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