FDAClass IIMay 1, 2019

Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1 recall: Sterility Concern

Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite…

Why was Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1 recalled?

Lack of sterility assurance.

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?

Lots: ED041902 Exp. 4/13/2019; ED051903 Exp. 04/14/2019; ED081902 Exp. 4/17/2019; ED091902 Exp. 4/18/2019; ED101903 Exp. 4/19/2019; ED111902 Exp. 4/20/2019

Product
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite…
Recalling firm
CMC Enterprise Pharmacy
Quantity
1135 syringes
Distribution
NC
Recall date
May 1, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls