Drug Enforcement D-0108-2023

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

January 18, 2023

Termination Date

June 21, 2023

Product Information

Product description
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Product quantity
6 vials
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Northern VA Compounders PLLC
Address
23475 Rock Haven Way, Suite 105

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0108-2023
Event ID
91443
Recall initiation date
December 30, 2022
Center classification date
January 12, 2023
Code info
Lot#: 12062022@1, Exp 1/20/2023
More code info
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