FDAClass IINovember 9, 2022

Papaverine / Phentolamine / Prostaglandin 150mg / 2.5mg recall: Sterility Concern

PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg…

Why was Papaverine / Phentolamine / Prostaglandin 150mg / 2.5mg 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: 64409, BUD: 04/08/2023; 60849, BUD: 05/23/2023

Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg…
Recalling firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Quantity
56 vials
Distribution
AL, LA, MS, and TN
Recall date
November 9, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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