Drug product
METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-0999-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-0999-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 02022016 : 72@19, Exp. 07/13/2016; Lot #: 02092016: 09@23, Exp. 08/08/2016; Lot #: 02262016:14@7, Exp. 08/27/2016; Lot #:03022016: 60@23, Exp. 08/21/2016; Lot #: 03012016:54@20, Exp.08/24/2016; Lot #: 03212016: 35@49, Exp. 09/17/2016; Lot #: 04142016: 15@2, Exp. 10/11/2016; Lot #: 04212016: 69@19, Exp.10/19/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility