The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0145-2023·Announced 2023-01-25

FDA recalls Akorn ophthalmic ointment for manufacturing process deviations

Akorn, Inc. is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment nationwide due to manufacturing process deviations. The recall is voluntary and initiated by the manufacturer.

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 initiated by the manufacturer. The source text does not identify a specific hazard or report any illnesses or injuries. Manufacturing process deviations without identified consequences fall under the 'voluntary precautionary recalls' category, warranting a Moderate severity rating.

Plain-English summary

Akorn, Inc., based in Lake Forest, Illinois, is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP (3.5 g / 1/8 oz. size, NDC 17478-235-35). The affected lot is Lot 1K64A with an expiration date of September 30, 2023, and was distributed nationwide throughout the United States.

The product is a prescription ophthalmic ointment used to treat eye infections. The FDA classified this as a Class II recall. The recall was voluntary and initiated by Akorn, Inc. on October 13, 2022.

The recall was issued in response to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process.

The recalled product

Product
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
2,082

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: Lot 1K64A
  • EXP 9/30/2023

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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