FDAClass IDecember 28, 2016

Lidocaine HCL/ Sodium Bicarb recall: Sterility Concern

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

Why was Lidocaine HCL/ Sodium Bicarb recalled?

Non-Sterility: failed sterility test result.

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 #: 50699:00, Exp 10/04/16

Product
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Recalling firm
Guardian Pharmacy Services
Quantity
180 syringes
Distribution
Two medical facilities in TX
Recall date
December 28, 2016
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls