FDA recall D-0194-2021

SCA Pharmaceuticals · Class II · drug

Product

Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809

Reason for recall

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Distribution

Product was distributed to hospitals nationwide.

Key facts

Status
Terminated
Initiation date
2020-12-17
Report date
2021-01-13
Termination date
2021-11-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0194-2021