Drug Enforcement D-0043-2023

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.

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Status

Ongoing

Classification

Class II

Report Date

November 9, 2022

Termination Date

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Product Information

Product description
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Product quantity
1 vial
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.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
AL, LA, MS, and TN

Location & Firm

Recalling firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Address
115 S 40th Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0043-2023
Event ID
90982
Recall initiation date
October 7, 2022
Center classification date
November 2, 2022
Code info
Lot: 66576, BUD: 11/09/2022
More code info
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