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ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx...

FDA Recall #D-0068-2018 — Class II — October 19, 2017

Recall #D-0068-2018 Date: October 19, 2017 Classification: Class II Status: Terminated

Product Description

ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09

Reason for Recall

Lack Of Assurance Of Sterility.

Recalling Firm

SCA Pharmaceuticals, LLC — Little Rock, AR

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

487 syringes

Distribution

Nationwide in the United States

Code Information

Lot: 20171004@4 BUD: 01/09/2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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