D-1008-2016 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
QUAD-MIX #4 (MOD), 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.
Distribution Pattern
NV
Code Information
Lot #: 02052016:96@38, Exp.05/09/2016; Lot #: 04052016: 39@6, Exp. 07/04/2016; Lot #: 04132016:79@19, Lot #: 07/13/2016.