D-0988-2016 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
1-HCG 1000 IU/ML, packaged in 5mL and 10mL 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 #: 01072016: 23@28, Exp. 04/06/2016; Lot #: 01082016: 27@1, Exp. 04/07/2016; Lot #:02012016:20@39, Exp. 05/01/2016; Lot #: 02022016:07@7, Exp.05/02/2016; Lot #: 02152016:29@50, Exp. 05/15/2016; Lot #: 02292016: 40@24, Exp.05/29/2016; Lot #: 02292016: 12@42 , Exp.05/29/2016; Lot #: 03042016:96@9, Exp.06/02/2016; Lot #: 03082016:59@34, Exp.06/08/2016 03142016:65@58, Exp.06/12/2016; Lot #: 03212016: 66@2, Exp.06/19/2016; Lot #: 03022016:50@38, Exp.06/23/2016; Lot #: 03302016: 93@11, Exp. 06/28/2016; Lot #: 04062016:79@22, Exp.07/07/2016; Lot #: 04122016 38@58, Exp.07/12/2016; Lot #: 04152016: 87@1, Exp. 07/14/2016; Lot #: 04152016:12@12, Exp. 07/14/2016; Lot #: 04222016: 55@27, Exp.07/21/2016