PlainRecalls
FDA Drug Moderate Class II Terminated

BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Reported: May 22, 2013 Initiated: April 10, 2013 #D-347-2013

Product Description

BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Reason for Recall

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.

Details

Units Affected
435 vials and syringes
Distribution
Nationwide
Location
Henderson, NV

Frequently Asked Questions

What product was recalled?
BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.. Recalled by FVS Holdings, Inc. dba. Green Valley Drugs. Units affected: 435 vials and syringes.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 22, 2013. Severity: Moderate. Recall number: D-347-2013.