M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well...
FDA Recall #D-0995-2016 — Class II — May 17, 2016
Product Description
M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/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.
Recalling Firm
Well Care Compounding Pharmacy — Las Vegas, NV
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
869 Units (Total All Products)
Distribution
NV
Code Information
Lot #: 01222016:57@21, Exp.03/33/2016; Lot #: 01222016: 78@51, Exp.04/25/2016; Lot #: 01272016:51@23, Exp. 03/27/2016; Lot #: 02292016:71@13, Exp. 04/29/2016; Lot #: 03022016:46@14, Exp. 06/22/2016; Lot #:04252016:20@62, Exp.06/24/2016; Lot #: 04262016:18@11, Exp.06/25/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated