D-1003-2016 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
MYERS' COCKTAIL, packaged in 37 mL 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 #: 01112016:29@20, Exp. 01/19/2016; Lot #:01202016: 85@9, Exp. 01/27/2016; Lot #: 01222016: 56@17, Exp. 01/29/2016; Lot #: 01222016:36@49, Exp.02/02/2016; Lot #: 01262016:72@12, Exp.02/02/2016; Lot #: 01262016: 56@58, Exp.02/03/2016; Lot #: 02052016:89@26, Exp.03/02/2016; Lot #: 02112016:55@39, Exp.03/03/2016; Lot #: 02102016: 95@17, Exp. 03/08/2016; Lot #: 02222016:39@46, Exp. 03/15/2016; Lot #: 04222016:40@48, Exp.03/16/2016; Lot #: 02262016:53@13, Exp.03/24/2016; Lot #: 03072016: 01@14, Exp. 03/29/2016; Lot #: 03082016:40@11, Exp.03/30/2016; Lot #: 3012016:90@30, Exp.04/07/2016; Lot #: 03012016:78@13, Exp.04/18/2016; Lot #: 03222016: 19@17 04/13/2016; Lot #: 0331201661@40, Exp.04/21/2016; Lot #: 04132016:89@17, Exp. 05/06/2016; Lot #: 04272016:35@45, Exp. 05/20/2016; Lot #: 04292016:70@27, Exp.05/23/2016.