Recalls / Class II
Class IID-379-2013
Product
Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Affected lot / code info
- Lot #: a) Lidocaine _HCl-0.5%: 20130403-J, 20130403-F, 20130403-H, 20130403-G, 20130403-I, Exp 7/3/2013; 2013117-I, Exp 4/17/2013; b) Lidocaine HCl: 20130131-H, Exp 4/30/2013; c) Lidocaine 1%: 20130204-N, Exp 5/4/2013; 20130115-A, Exp 4/15/2013; 20130128-E, Exp 4/28/2013; 20130220-G, Exp 5/20/2013; 20130221-J, Exp 5/21/2013; 20130221-K, Exp 5/21/2013; 20130204-J, Exp 5/4/2013; 20130315-J, Exp 6/15/2013; 20130315-K, Exp 6/15/2013; 20130328-E, Exp 6/28/2013; 20130328-H, Exp 6/28/2013; 20130328-I, Exp 6/28/2013; 20130328-K, Exp 6/28/2013; 20130329-B, Exp 6/29/2013; 20130329-C, Exp 6/29/2013; 20130304-K, Exp 6/4/2013; 20130304-L, Exp 6/4/2013; 20130305-L, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130306-H, Exp 6/6/2013; 20130306-P, Exp 6/6/2013; 20130307-J, Exp 6/7/2013; 20130115-B, Exp 4/15/2013; 20130201-M, Exp 5/1/2013; 20130214-A, Exp 5/14/2013; 20130204-M, Exp 5/4/2013; 20130328-F, Exp 6/28/2013; 20130329-A, Exp 6/29/2013; 20130305-M, Exp 6/5/2013; 20130305-D, Exp 6/5/2013; 20130328-J, Exp 6/28/2013; d) Lidocaine 1% 50 ml: 20130128-D, 4/28/2013; 20130115-D, Exp 4/15/2013; 20130115-F, Exp 4/15/2013; 20130117-H, Exp 4/17/2013; 20130115-C, Exp 4/15/2013; e) Lidocaine 2 %: 20130325-F, Exp 6/25/2013; 20130130-N, Exp 4/30/2013; 20130221-L, Exp 5/21/2013; 20130221-N, Exp 5/21/2013; 20130228-I, Exp 5/28/2013; 20130314-H, Exp 6/14/2013; 20130314-I, Exp 6/14/2013; 20130315-E, Exp 6/15/2013; 20130315-F, Exp 6/15/2013; 20130318-K, Exp 6/18/2013; 20130320-D, Exp 6/20/2013; 20130320-B, Exp 6/20/2013; 0130328-D, Exp 6/28/2013; 20130328-G, Exp 6/28/2013; 20130305-E, Exp 6/5/2013; 20130130-M, Exp 4/30/2013; 20130221-M, Exp 5/21/2013; 20130221-O, Exp 5/21/2013; 20130325-E, Exp 6/25/2013; f) Lidocaine 2% 50ml: 20130320-C, Exp 6/20/2013; 20130305-F, Exp 6/5/2013; 20130305-I, Exp 6/5/2013; 20130301-A, Exp 6/1/2013; 20130304-L, Exp 6/4/2013; g) Lidocaine 2% 50ml MDV: 20130227-E, Exp 5/27/2013
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
- 3946 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-379-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.