Recall: D-1046-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-13Initiated

TerminatedStatus

Mckesson Medical-Surgical Inc.Firm

Product

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

Reason

cGMP deviations: Temperature abuse

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.