PlainRecalls
FDA Drug Moderate Class II Terminated

HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1046-2022

Product Description

HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
30 bottles/100 capsules per bottle
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 30 bottles/100 capsules per bottle.
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-1046-2022.