The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0483-2019·Announced 2019-02-20

Akorn Recalls COSOPT Ophthalmic Solution Due to Stability Failures

Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution because the product failed stability specifications for opalescence.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution, USP (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle. The recall involves lots 426007 and 426008 with an expiration date of 4/2020. The product is distributed nationwide in the United States and Puerto Rico.

The recall was initiated because the product failed stability specifications, specifically showing out-of-specification results for opalescence during a 7-month stability study. The U.S. Food and Drug Administration has classified this as a Class III recall.

Consumers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The recalled product is identified by NDC 17478-605-10.

The recalled product

Product
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
Manufacturer
Akorn Inc
Category
Drug — Ophthalmic
Hazard
Affected units
30,794

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 (2)

  • Lots: 426007 and 426008
  • exp 4/2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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