FDA recall D-0191-2017

Product

Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15

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-0191-2017