FDAClass IIJanuary 13, 2021

Lidocaine HCl 1% recall: Sterility Concern

Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012

Why was Lidocaine HCl 1% recalled?

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

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 # 1220023097, BUD 1/25/2021; 1220023134, BUD 1/25/2021 & 1220023326, BUD 2/1/2021

Product
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
Recalling firm
SCA Pharmaceuticals
Quantity
1,880 syringes
Distribution
Product was distributed to hospitals nationwide.
Recall date
January 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls