D-1003-2016 Class II Terminated
FDA drug recall D-1003-2016 was initiated by Well Care Compounding Pharmacy on May 17, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. The recall status is terminated (terminated January 13, 2017). Affected quantity: 869 Units (Total All Products).
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.