Drug product
1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-0988-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-0988-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
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
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility