US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 17, 2016 (10 years ago)

Mb 12/Hxb 12/Fa/P5p/

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

What was recalled

MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Recalling firm
Well Care Compounding Pharmacy
Origin
NV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0997-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.