Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection ...

FDA Recall #D-0202-2017 — Class II — November 18, 2016

Recall #D-0202-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15

Reason for Recall

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Recalling Firm

Cantrell Drug Company — Little Rock, AR

Classification

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

Product Type

Drugs

Product Quantity

5067 syringes

Distribution

Nationwide

Code Information

Lot: 8995

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated