PlainRecalls
FDA Drug Moderate Class II Terminated

Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1105-2022

Product Description

Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
50 bottles
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 50 bottles.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1105-2022.