FDA recall D-1079-2017

Product

Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15

Reason for recall

Lack of Sterility Assurance.

Distribution

Nationwide within the US

Key facts

Status

Terminated

Initiation date

2017-07-14

Report date

2017-08-16

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1079-2017