FDA recall D-0960-2023

Product

PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.

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-0960-2023