FDA Class II Drug Recall: TOBRADEX Ophthalmic Ointment, Temperature Abuse
McKesson Medical-Surgical is recalling TOBRADEX ophthalmic ointment nationwide due to cGMP deviations involving temperature abuse. Product distributed between June 1 and September 30, 2021 may be affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II drug recall with cGMP deviations related to temperature abuse. No illnesses, injuries, or hospitalizations have been reported. This meets the Moderate threshold as a manufacturing deviation without reported harm or high-risk contamination.
Plain-English summary
TOBRADEX (tobramycin and dexamethasone) ophthalmic ointment, 3.5 gm, is being recalled nationwide by McKesson Medical-Surgical Inc. The original manufacturer is Novartis.
The recall was initiated due to cGMP deviations involving temperature abuse during manufacturing or storage.
Product distributed to customers between June 1 and September 30, 2021 is affected. McKesson Medical-Surgical notes that specific lot numbers cannot be identified by distributor, so customers should use their own records to determine if they received recalled product during this timeframe and whether any remains in inventory.
Customers and healthcare providers with questions should contact Sedgwick. Patients using this medication should consult their healthcare provider regarding this recall.
The recalled product
- Product
- TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE)
- Brand
- TOBRADEX
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic / Prescription
- Affected units
- 3
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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