D-1009-2016 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
SUPER TRI-MIX #1, 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 #: 01062016:29@49, Exp.04/06/2016; Lot #: 02032016: 30@5, Exp.05/03/2016; Lot #: 03312016:91@17; Exp. 06/29/2016; Lot #: 03302016:17@40, Exp. 06/30/2016; Lot 4132016:46@20, Exp. 07/12/2016.