FDA recall D-0965-2023

Central Admixture Pharmacy Services, Inc. · Class II · drug

Product

PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1

Reason for recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-07-14
Report date: 2023-08-09
Termination date: 2025-03-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0965-2023