FDAClass IIJanuary 18, 2023

BiMix STD 001 recall: Sterility Concern

BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475…

Why was BiMix STD 001 recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot#: 10252022@3, Exp 1/31/2023

Product
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475…
Recalling firm
Northern VA Compounders PLLC
Quantity
1200 vials
Distribution
Nationwide in the USA
Recall date
January 18, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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