The Recall Desk
HighFDA (Drugs)·D-1105-2022·Announced 2022-06-15

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.

What this means for you

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
  • temperature-abuse

Distribution

Distributed nationwide across the United States.

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