PlainRecalls
FDA Drug Moderate Class II Ongoing

PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Reported: November 9, 2022 Initiated: October 7, 2022 #D-0046-2023

Product Description

PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 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.

Details

Units Affected
242 vials
Distribution
AL, LA, MS, and TN
Location
Hattiesburg, MS

Frequently Asked Questions

What product was recalled?
PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402. Recalled by Pharmacy Plus, Inc. dba Vital Care Compounder. Units affected: 242 vials.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 9, 2022. Severity: Moderate. Recall number: D-0046-2023.