The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0140-2023·Announced 2023-01-25

FDA recalls GONAK ophthalmic drug solution for manufacturing deviations

Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.

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 2/5 (Moderate).

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 a Class II voluntary recall initiated by the manufacturer due to CGMP deviations. No illnesses or injuries are reported in the source. The rubric specifies that voluntary precautionary recalls are classified as Moderate.

Plain-English summary

Akorn, Inc. initiated a voluntary recall of GONAK Hypromellose Ophthalmic Demulcent Solution, a professional-use eye drop solution for gonioscopic examinations. The product is supplied in 15 mL dropper bottles containing 2.5% hypromellose (25 mg formulation), with NDC 17478-064-12.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. Akorn initiated the recall on October 13, 2022, and the FDA classified it as a Class II recall on January 13, 2023.

Approximately 196,254 bottles were distributed nationwide in the United States. Multiple lot numbers are affected with expiration dates ranging from January 2023 through November 2023.

This recall remains ongoing. Healthcare professionals and facilities should verify inventory against the provided lot numbers and expiration dates to identify affected products.

The recalled product

Product
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
196,254

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: 0C80A
  • EXP 2/28/2023
  • 0B71A
  • 1B32A
  • EXP 1/31/2023
  • 0C80B
  • 0F68A
  • EXP 5/31/2023
  • 0G85A
  • 0G01A
  • 1G54A
  • 1G71A
  • EXP 6/30/2023
  • 0H32A
  • 0H47A
  • 1H75A
  • EXP 7/31/2023
  • 0K22A
  • EXP 9/30/2023
  • 0M90A

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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