D-1002-2016 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/FOLIC ACID; 10MG/0.8MG/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 #: 01262016:86@2, Exp. 07/30/2016; 02222016:31@27, Exp. 08/20/2016; Lot #: 03022016:1@47, Exp. 08/29/2016; Lot #: 03032016:26@ 1, Exp. 08/30/2016; Lot #: 04122016: 84@227, Exp.10/15/2016.