FDAClass IIMay 22, 2013

BET-ACE-LIDO-6-2 Injection recall: Sterility Concern

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…

Why was BET-ACE-LIDO-6-2 Injection 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 13012320-GV1, Exp 4/23/2013; 13021840GV1, Exp 5/18/2013; 13031150GV1, Exp 6/11/2013; 13021840GV1, Exp 5/18/2013; 13012320-GV1, Exp 4/23/2013; 13011532, Exp 4/15/2013.

Product
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…
Recalling firm
FVS Holdings, Inc. dba. Green Valley Drugs
Quantity
435 vials and syringes
Distribution
Nationwide
Recall date
May 22, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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