Akorn recalls Gonak Hypromellose Ophthalmic Solution 25mg/mL 15mL bottles due to inability to conduct stability studies after the company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled Gonak Hypromellose Ophthalmic Solution 25mg/mL 15mL bottles because the manufacturer went out of business and can no longer perform stability testing. This means the product's safety and effectiveness cannot be confirmed.
The manufacturer went out of business and could no longer conduct stability studies. This means the product's safety and effectiveness cannot be confirmed over time.
Prescription eye drops for medical use. Patients with a prescription for Gonak are most at risk.
Look for Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles with a prescription. All National Drug Codes (NDCs) and all production lots are affected.
Confirm you have a prescription for Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles.
The manufacturer went out of business and can no longer confirm the product's safety and effectiveness through stability testing.
All Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles with a prescription are affected, including all National Drug Codes (NDCs) and production lots.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0805-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0805-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
