Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Particulate Matter
Akorn, Inc. is recalling specific lots of Gentamicin Sulfate Ophthalmic Solution because crystalline particles were detected during clarity testing.
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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is particulate matter, which is a quality defect rather than a high-risk pathogen or structural failure, fitting the Moderate severity criteria for low-risk contamination or labeling/quality errors without reported serious injury.
Plain-English summary
Akorn, Inc. is recalling 149,159 bottles of Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottles. The affected product is identified by NDC 17478-283-10 and includes lots 6C02A (Exp. 02/19), 5K42A (Exp. 09/2018), and 7D47A (Exp. 03/2020).
The recall was initiated because crystalline particles were noticed at the 24-month clarity testing. The product was distributed nationwide in the United States and Puerto Rico.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- 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 (3)
- Lots: 6C02A Exp. 02/19
- 5K42A Exp. 09/2018
- 7D47A Exp. 03/2020
Distribution
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