Prednisolone Acetate ophthalmic suspension recalled for temperature-abuse during distribution
Prednisolone Acetate ophthalmic suspension is being recalled nationwide due to temperature deviations during distribution. McKesson Medical-Surgical has notified affected customers.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard (temperature-induced degradation of the suspension) is theoretical. Per the rubric, FDA Class II without reported hospitalization scores at most 3 when the hazard is theoretical.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Prednisolone Acetate Ophthalmic Suspension, USP 1% (5 mL bottles) distributed nationwide to U.S. customers. The recall is due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during distribution.
Prednisolone acetate is a corticosteroid eye suspension. Temperature exposure during storage and transport can affect the quality and stability of pharmaceutical suspensions.
Consumers and healthcare providers who have received affected product should not use it. Contact McKesson Medical-Surgical or speak with your pharmacist or healthcare provider for replacement product or other guidance.
No illnesses or injuries have been reported to date.
The recalled product
- Product
- PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
- Brand
- PREDNISOLONE ACETATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic Corticosteroid
- Hazard
- Affected units
- 50
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.
See all 130 products in this recall →Related recalls
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