Mckesson Medical-Surgical recalls Ofloxacin Otic Solution 0.3% 5mL bottles (NDC 69238-1615-3) due to temperature abuse. The recall is for prescription-only products with potential for improper storage affecting safety.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical is recalling prescription Ofloxacin Otic Solution 0.3% 5mL bottles because of temperature abuse risks. This could lead to improper storage conditions that affect product safety.
Temperature abuse means the product may have been stored at unsafe temperatures, which can compromise its effectiveness and safety. This could lead to improper medication delivery or potential harm if used incorrectly.
Prescription holders of Ofloxacin Otic Solution 0.3% 5mL bottles from Amneal/Akyma Pharmaceuticals (NDC 69238-1615-3) are affected. Patients using this ear drop medication are most at risk if stored improperly.
Check for the 5mL bottle labeled 'Ofloxacin Otic Solution 0.3%' with NDC 69238-1615-3. The product is prescription-only and distributed by Mckesson Medical-Surgical.
Identify the product by checking the label for 'Ofloxacin Otic Solution 0.3%' and NDC 69238-1615-3.
The recall indicates potential temperature abuse risks, but the official notice does not specify if the product is safe to use.
Look for the 5mL bottle labeled 'Ofloxacin Otic Solution 0.3%' with NDC 69238-1615-3, which is prescription-only.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the product.
We’ve drafted a message you can send Mckesson Medical-Surgical to request your refund or repair — edit it as you like.
Subject: Recall D-1114-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1114-2022 from Mckesson Medical-Surgical. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
