Mckesson Medical-Surgical recalls TobraDex (tobramycin and dexamethasone) ophthalmic ointment due to temperature abuse risks. Affected products were distributed between June 1 and September 30, 2021.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical has recalled TobraDex ophthalmic ointment (3.5 gm, Rx only) because of temperature abuse risks. This could lead to product degradation if not stored properly, potentially affecting safety and effectiveness.
The ointment was recalled due to cGMP deviations related to temperature abuse. This means the product may have been exposed to temperatures that could cause degradation, potentially affecting its safety and effectiveness.
Healthcare providers and pharmacies that received TobraDex ointment from Mckesson Medical-Surgical between June 1 and September 30, 2021. Patients using the product under a prescription are not directly affected by the recall.
Check if your pharmacy received TobraDex ointment from Mckesson Medical-Surgical between June 1 and September 30, 2021. The product has NDC 0078-0876-01 and is a prescription-only ophthalmic ointment.
Use your pharmacy's records to determine if you received TobraDex ointment from Mckesson Medical-Surgical between June 1 and September 30, 2021.
The recall is due to temperature abuse risks, not immediate danger if used correctly. The product is safe when stored properly.
No, the recall does not require stopping use. Healthcare providers should check their records to see if they received affected products.
Check if your pharmacy received TobraDex ointment from Mckesson Medical-Surgical between June 1 and September 30, 2021. The product has NDC 0078-0876-01 and is prescription-only.
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-0995-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-0995-2022 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.
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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.
