Recalls / Class II
Class IID-339-2013
Product
Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Affected lot / code info
- Lot #: 20130129-J, 20130129-L, Exp 04/29/13; 20130405-H, Exp 07/05/13.
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
- 93 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-339-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.