Pharmacy Innovations recalls 0.2% polyhexamidine ophthalmic solution due to FDA finding of insanitary conditions at manufacturing facility. This may pose a risk of contamination.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Pharmacy Innovations is recalling a specific ophthalmic solution product because FDA inspections found unsanitary conditions at their facility. This could lead to contamination risks for users.
FDA inspections found unsanitary conditions at the manufacturing facility. This could lead to contamination of the solution, potentially causing infections or other health issues when used in the eye.
People who have purchased this ophthalmic solution from pharmacies or online retailers. Those with eye conditions requiring this medication are at higher risk.
This product is labeled as POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only. It was sold by Pharmacy Innovations at their location in Erie, PA.
Look for the product name and manufacturer details on the container.
The FDA found unsanitary conditions at the facility, so this product may be contaminated. Do not use it.
The recall record does not specify a replacement option.
The recall record does not provide specific instructions for disposal or return.
We’ve drafted a message you can send Pharmacy Innovations to request your refund or repair — edit it as you like.
Subject: Recall D-0232-2023 — Pharmacy Innovations Pharmacy Innovations Hello, I own a Pharmacy Innovations that is covered by recall D-0232-2023 from Pharmacy Innovations. 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.
