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FDAFDA · Food and drugs·Recall number D-0997-2016

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

Published June 15, 2016 · Recall initiated: May 17, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Press Release

Recall details

Manufacturer
Well Care Compounding Pharmacy
Distributor
NV
Lot
Lot #: 01182016:46@7, Exp.04/17/2016; Lot #: 02192016 60@29, Exp. 05/19/2016; Lot #: 04082016:83@53; Exp. 07/11/2016; Lot #: 04202016:61@66, Exp.07/19/2016.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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