D-1000-2016 Class II Terminated
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
- 869 Units (Total All Products)
Product Description
METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 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 #: 01062016: 32@16, Exp.04/06/2016; Lot #: 01252016: 96@51, Exp. 07/23/2016; Lot #: 03302016: 68@42, Exp. 09/25/2016; Lot #: 04042016:11@27, Exp.10/02/2016; Lot #: 04122016: 90@15, Exp. 10/09/2016 04202016:57@13, Exp.10/22/2016.