Recalls / Class II
Class IID-351-2013
Product
Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Affected lot / code info
- Lot #: 13011450GV4, 13011450GV1, Exp 4/14/2013; 13011760B, Exp 4/17/2013; 13012450, Exp 4/24/2013; 13021960GV2, Exp 5/19/2013; 2013021950GV2, Exp 5/19/2013; 20130222GV3, Exp 5/22/2013; 13020450GV3, Exp 5/4/2013; 13020850GV2, Exp 5/8/2013; 13031330GV2, Exp 6/13/2013; 13032730GV1, Exp 6/27/2013; 20130327GV2, Exp 6/27/2013; 1303031475GV2, Exp 6/3/2013; 130301100GV2, Exp 6/1/2013
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
- 1150 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-351-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.