FDA recall D-0052-2023

Pharmacy Plus, Inc. dba Vital Care Compounder · Class II · drug

Product

PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Reason for recall

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Distribution

AL, LA, MS, and TN

Key facts

Status: Ongoing
Initiation date: 2022-10-07
Report date: 2022-11-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hattiesburg, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0052-2023