The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0139-2023·Announced 2023-01-25

FDA Recalls Nationwide Supply of Erythromycin Ophthalmic Ointment for Manufacturing Deviations

Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall based on manufacturing process deviations that could affect product quality and safety. Although no illnesses or injuries have been reported, the lack of compliance with manufacturing standards poses a potential risk of harm to patients using the ophthalmic ointment.

Plain-English summary

Akorn, Inc. is recalling Erythromycin Ophthalmic Ointment USP 0.5% (NDC 17478-070-31) due to current good manufacturing practice (CGMP) deviations. The recall affects 36,455 cartons distributed nationwide in the United States. This is a voluntary Class II recall initiated by the company on October 13, 2022, and classified by the FDA on January 13, 2023. No illnesses or injuries have been reported.

The following lot numbers are affected with their expiration dates: Lot 1B14B (1/31/2023); Lots 1C49A, 1C49B, 1C70A (2/28/2023); Lots 1E09A, 1E34A, 1E34B, 1E09B (4/30/2023); Lots 1F37C, 1F37A, 1F37B (5/31/2023); Lots 1G58A, 1G57B, 1G58B, 1G66B, 1G66A, 1G57A (6/30/2023); Lots 1H77B, 1H80A, 1H80B, 1H77A (7/31/2023); Lot 1J24A (8/31/2023); Lots 1K67B, 1K67A, 1K76A, 1K87B, 1K77A, 1K76B, 1K87A, 1K77B (9/30/2023); Lots 1L90B, 1L90A, 1L92B, 1L92A (10/31/2023); Lots 1M28A, 1M35A, 1M28B (11/30/2023); and Lot 2D20B (3/31/2024).

Healthcare providers and patients should stop using the recalled product. Those with questions or concerns about adverse effects should contact Akorn, Inc. or the FDA. The recall is ongoing.

The recalled product

Product
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
36,455

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: 1B14B
  • EXP 1/31/2023
  • 1C49A
  • 1C49B
  • 1C70A
  • EXP 2/28/2023
  • 1E09A
  • 1E34A
  • 1E34B
  • 1E09B
  • EXP 4/30/2023
  • 1F37C
  • 1F37A
  • 1F37B
  • EXP 5/31/2023
  • 1G58A
  • 1G57B
  • 1G58B
  • 1G66B
  • 1G66A

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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