Akorn recalls 15mL piloc:1% ophthalmic solution bottles due to stability concerns after manufacturer went out of business. No remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 15mL pilocarpine eye drops (1%) that were distributed by their company. The recall happens because the manufacturer went out of business and can no longer conduct stability testing on the product.
The manufacturer went out of business and can no longer perform stability studies on the product. This means the product's safety and effectiveness over time cannot be confirmed.
Prescription eye drop users who have the 15mL bottles labeled as pilocarpine hydrochloride ophthalmic solution 1% (Rx only). People with the product are most at risk.
Check for 15mL bottles labeled 'Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, Rx Only'. All NDCs and lots are affected.
Look for 15mL bottles labeled 'Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, Rx Only'.
The manufacturer went out of business and can no longer continue stability studies on the product.
No remedy is provided in the official recall notice.
Check for 15mL bottles labeled 'Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, Rx Only'. All NDCs and lots are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0835-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0835-2023 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.
