The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0993-2019·Announced 2019-03-20

Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Impurities

Akorn, Inc. is recalling Gentamicin Sulfate Ophthalmic Solution, 0.3%, due to high out-of-specification impurities found during stability 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall with potential for adverse health consequences (impurities) maps to a score of 4 (Severe), as it is not Class I (Critical) but exceeds the threshold for High (3) due to the agency's specific classification of the risk.

Plain-English summary

Akorn, Inc. is recalling 51,456 bottles of Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle (NDC 17478-283-10). The affected product is identified by Lot 7B71A with an expiration date of 01/2020. The recall was initiated because high out-of-specification (OOS) results were identified for individual and total impurities at the 18-month stability testing time point.

The product was distributed nationwide in the United States and Puerto Rico. This is a prescription-only medication. The FDA has classified this recall as Class II, which indicates 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.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on alternatives. Patients should not discard the medication until instructed by a healthcare professional or the manufacturer.

The recalled product

Product
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
51,456

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 7B71A
  • Exp 01/2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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