FDAFDA · Food and drugs·Recall number D-0999-2016
METHYLCOBALAMIN 12.5MG/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 #: 02022016 : 72@19, Exp. 07/13/2016; Lot #: 02092016: 09@23, Exp. 08/08/2016; Lot #: 02262016:14@7, Exp. 08/27/2016; Lot #:03022016: 60@23, Exp. 08/21/2016; Lot #: 03012016:54@20, Exp.08/24/2016; Lot #: 03212016: 35@49, Exp. 09/17/2016; Lot #: 04142016: 15@2, Exp. 10/11/2016; Lot #: 04212016: 69@19, Exp.10/19/2016.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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