Akorn recalls GONAK Hypromellose Ophthalmic Demulcent Solution for CGMP deviations. This product is for professional use in ophthalmic examinations. Affected lots and expiration dates listed.
CGMP Deviations:
Akorn has recalled GONAK Hypromellose Ophthalmic Demulcent Solution due to CGMP deviations. This product is intended for professional use in eye examinations. The recall affects specific lots with varying expiration dates.
The recall mentions CGMP deviations, which are regulatory issues in manufacturing quality control. However, the specific hazard mechanism is not detailed in the notice. Without clear information on how this affects safety, the risk level cannot be determined.
Healthcare professionals who use this product for eye examinations are likely affected. The risk is not clearly described in the recall notice.
Check the product label for the NDC code 17478-064-12 and lot numbers like 0C80A, 0B71A, 0C80B, 0F68A, 0G85A, 0G01A, 1G54A, 1G71A, 0H32A, 0H47A, 1H75A, 0K22A, 0M90A. The product expires between January 31, 2023 and November 30, 2023.
Look for the NDC code 17478-064-12 and lot numbers listed in the recall notice.
The recall notice states CGMP deviations but does not specify if the product is safe. Without clear hazard details, the safety cannot be confirmed.
The recall does not provide a remedy, so no specific action is required beyond checking the product label for affected lots.
Check the product label for the NDC code 17478-064-12 and lot numbers like 0C80A, 0B71A, 0C80B, 0F68A, 0G85A, 0G01A, 1G54A, 1G71A, 0H32A, 0H47A, 1H75A, 0K22A, 0M90A.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0140-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0140-2023 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.
