Drug product
METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-1000-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-1000-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01062016: 32@16, Exp.04/06/2016; Lot #: 01252016: 96@51, Exp. 07/23/2016; Lot #: 03302016: 68@42, Exp. 09/25/2016; Lot #: 04042016:11@27, Exp.10/02/2016; Lot #: 04122016: 90@15, Exp. 10/09/2016 04202016:57@13, Exp.10/22/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility