The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0157-2023·Announced 2023-01-25

Prescription Eye Drops Recalled for Manufacturing Control Deviations

Akorn, Inc. is voluntarily recalling over 2 million bottles of Tobramycin Ophthalmic Solution due to Current Good Manufacturing Practice deviations affecting four product lots distributed nationwide.

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: FDA Class II recall for Current Good Manufacturing Practice deviations affecting 2.1 million bottles of an ophthalmic solution distributed nationwide. While no illnesses have been reported, ophthalmic solutions are risk-of-harm products requiring strict manufacturing controls due to the sensitivity of eye tissues.

Plain-English summary

Tobramycin Ophthalmic Solution, USP 0.3%, 5 mL per dropper bottle, manufactured by Akorn, Inc. of Lake Forest, Illinois, is being recalled. The product carries NDC (National Drug Code) 17478-290-10, and approximately 2,095,068 bottles are affected.

The recall was initiated by Akorn, Inc. due to Current Good Manufacturing Practice (CGMP) deviations. The recall applies to four specific lots: Lot 1C56A (expiration 2/28/2023), Lot 1J50A (expiration 8/31/2023), Lot 1K61A (expiration 9/30/2023), and Lot 1M27A (expiration 11/30/2023).

The product was distributed nationwide in the United States. The firm voluntarily initiated the recall on October 13, 2022, which was classified as FDA Class II by the FDA on January 13, 2023. The recall status is ongoing.

Patients and healthcare providers who have or use affected lots should consult with their prescribing provider or pharmacist regarding this recall.

The recalled product

Product
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
2,095,068

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 (8)

  • Lot: 1C56A
  • EXP 2/28/2023
  • 1J50A
  • EXP 8/31/2023
  • 1K61A
  • EXP 9/30/2023
  • 1M27A
  • EXP 11/30/2023

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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