The Recall Desk
ModerateFDA (Drugs)·D-0158-2023·Announced 2023-01-25

FDA Recalls Tobramycin Ophthalmic Solution for Manufacturing Compliance Issues

Akorn, Inc. is recalling 91,692 bottles of Tobramycin Ophthalmic Solution (0.3%) nationwide due to Current Good Manufacturing Practice deviations. The voluntary recall was initiated on October 13, 2022.

What this means for you

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 recall issued for Current Good Manufacturing Practice deviations with no reported illnesses or injuries. It represents a voluntary precautionary recall, qualifying it as Moderate per the rubric.

Plain-English summary

Akorn, Inc. is recalling Tobramycin Ophthalmic Solution, USP, 0.3% (5 mL bottles) distributed nationwide in the United States. The affected lots are 1D94A (expiration 3/31/2023), 1E35A (expiration 4/30/2023), and 2A06A (expiration 12/31/2023). A total of 91,692 bottles are affected. The product is manufactured by Akorn, Inc. in Lake Forest, Illinois, and was distributed by MWI in Boise, Idaho.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. This voluntary recall was initiated by Akorn, Inc. on October 13, 2022, and was formally classified by the FDA on January 13, 2023.

This recall affects healthcare providers and patients who received or used Tobramycin Ophthalmic Solution with the affected lot numbers. The product is a prescription eye drop medication used to treat bacterial eye infections.

Patients should consult with their healthcare provider regarding their use of the recalled product. Healthcare providers should review patient records to identify individuals who may have received the affected lots and take appropriate action.

The recalled product

Product
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • manufacturing-deviation

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 (6)

  • Lot: 1D94A
  • EXP 3/31/2023
  • 1E35A
  • EXP 4/30/2023
  • 2A06A
  • EXP 12/31/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category