FDA recall D-0044-2023

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

Product

PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, 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-0044-2023