Drug product
Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-354-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 vials
- Official record key
drug-enforcement:D-354-2013
Official wording
Reason: Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Code information: Lot #: 20130130-A, Exp 4/30/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility