Recalls / Class II
Class IID-354-2013
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.
- Affected lot / code info
- Lot #: 20130130-A, Exp 4/30/2013
Why it was recalled
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.
Recalling firm
- Firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1850 Whitney Mesa Dr, Suite 180, Henderson, Nevada 89014-2091
Distribution
- Quantity
- 18 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-10
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2014-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-354-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.