Recalls / Class II
Class IID-411-2013
Product
Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Affected lot / code info
- Lot #: Taurine 50 mg/mL: 20130305-A, Exp 6/5/2013; Taurine-50-30 mL: 20130123-D, Exp 4/23/2013; Taurine-50mg-30 mL: 21030117-J, Exp 4/17/2013
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
- 50 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-411-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.