FDA recall D-0865-2023

Empower Clinic Services LLC dba Empower Pharmacy · Class II · drug

Product

ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1

Reason for recall

Mislabeling: preservative free product labeled as preserved.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Completed
Initiation date
2023-05-12
Report date
2023-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0865-2023