FDA recall D-0416-2024

Product

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-11-09

Report date

2024-04-03

Termination date

2024-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2024