The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0138-2023·Announced 2023-01-25

Drug Recall: Erythromycin Ophthalmic Ointment Due to Manufacturing Deviations

Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.

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: FDA Class II voluntary recall due to CGMP deviations with no illnesses or injuries reported. Meets rubric criterion for 'voluntary precautionary recalls' lacking specific evidence of adverse health consequences.

Plain-English summary

Akorn, Inc. is recalling Erythromycin Ophthalmic Ointment USP 0.5% distributed nationwide in the United States. The product is supplied in 3.5g (1/8 oz) tubes (NDC 17478-070-35), with approximately 1.1 million tubes affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations during the manufacturing process. This is a Class II voluntary recall initiated by Akorn, Inc. in October 2022.

Multiple lot numbers with expiration dates ranging from October 2022 through April 2024 are included in this recall. The complete list of affected lot numbers and expiration dates is available from the FDA.

This is a prescription medication. Patients currently using this product should contact their healthcare provider or pharmacist regarding their supply and to determine whether an alternative medication should be used.

The recalled product

Product
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Medication
Hazard
Affected units
1,109,600

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 (20)

  • Lot: 0L58A
  • EXP 10/31/2022
  • 1B21A
  • 1B31A
  • EXP 1/31/2023
  • 1C44A
  • 1C58A
  • 1C58B
  • EXP 2/28/2023
  • 1E13A
  • 1E24A
  • EXP 4/30/2023
  • 1C57A
  • 1G60A
  • 1G62A
  • 1G63A
  • EXP 6/30/2023
  • 1J34B
  • 1J40A
  • 1J21A

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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