FDAClass IIJanuary 13, 2021

Esmolol HCl 100 mg/10 mL recall: Sterility Concern

Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012

Why was Esmolol HCl 100 mg/10 mL 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 # 1220023042, BUD 1/21/2021

Product
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
Recalling firm
SCA Pharmaceuticals
Quantity
952 syringes
Distribution
Product was distributed to hospitals nationwide.
Recall date
January 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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