FDAClass IIJuly 18, 2018

Buffered Lidocaine 1% with Sodium Bicarbonate Injection recall: Subpotent

Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA…

Why was Buffered Lidocaine 1% with Sodium Bicarbonate Injection recalled?

Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.

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 #: 20180507@21, Exp 7/1/2018; 20180511@9, 20180511@24, Exp 7/5/2018; 20180518@24, 20180518@31, 20180518@32, Exp 7/12/2018; 20180531@21, Exp 7/25/2018; 20180601@11, Exp 7/26/2018

Product
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA…
Recalling firm
SCA Pharmaceuticals
Quantity
3984 syringes
Distribution
United States
Recall date
July 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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