The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0141-2023·Announced 2023-01-25

Ketorolac Tromethamine ophthalmic solution recalled due to manufacturing deviations

Akorn is recalling Ketorolac Tromethamine Ophthalmic Solution nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers of the 0.5% formulation.

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 classification indicates potential for serious adverse health consequences. No illnesses or injuries have been reported, but the manufacturing deviations in this sterile ophthalmic product pose a risk to patient safety.

Plain-English summary

Akorn, Inc. is recalling Ketorolac Tromethamine Ophthalmic Solution, 0.5%, nationwide due to manufacturing practice deviations. The recall affects the drug in 3 mL, 5 mL, and 10 mL dropper bottles distributed across the United States.

The deviations from Current Good Manufacturing Practice (CGMP) standards were identified at the firm's facility in Lake Forest, Illinois. Multiple lot numbers are affected, with expiration dates ranging from October 2022 through September 2023. This is a voluntary recall initiated by the manufacturer in October 2022.

Consumers or healthcare providers who have this product should not use it. Contact your pharmacy or healthcare provider to discuss your treatment options and how to properly return or dispose of the recalled medication.

The recalled product

Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard

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: (a) 1A09A
  • EXP 12/31/2022
  • 1H01A
  • EXP 7/31/2023
  • (b) 1E32A
  • EXP 4/30/2023
  • 1F45A
  • EXP 5/31/2023
  • 1H99A
  • 1K84A
  • EXP 9/30/2023
  • (c) 0L40A
  • EXP 10/31/2022
  • 1B38A
  • EXP 1/31/2023
  • 1E12A
  • 1F41A
  • 1G73A
  • 1G68A
  • EXP 6/30/2023

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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