D-0998-2016 Class II Terminated

Recalled by Well Care Compounding Pharmacy — Las Vegas, NV

Recall Details

Product Type
Drugs
Report Date
June 15, 2016
Initiation Date
May 17, 2016
Termination Date
January 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason for Recall

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

Distribution Pattern

NV

Code Information

Lot #: 01272016:00@24, Exp.03/28/2016; Lot #: 03292016: 96@35, Exp. 05/24/2016