FDA recall D-0195-2017

Product

HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-11-18

Report date

2016-12-21

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0195-2017