Agency classClass IIOur severity:Severe FDA (Drugs)·D-0107-2022·Announced 2021-11-17

BI-MIX Papaverine/Phentolamine Injectable Recalled for Sterility Assurance

Talon Compounding Pharmacy is recalling BI-MIX Papaverine 40/Phentolamine 2 injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States, Washington D.C., and Puerto Rico.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug where sterility assurance is compromised. Non-sterile injectable products present direct risk of serious infection and may require hospitalization. Class II recalls of sterile injectables warrant a Severe classification per the rubric.

Plain-English summary

Talon Compounding Pharmacy, operating as Vita Pharmacy, LLC, is recalling BI-MIX Papaverine 40/Phentolamine 2 injectable medication distributed as a 1 vial package. The product is a prescription-only injectable formulation.

The recall was issued because there is a lack of assurance of sterility for the affected vials. This injectable medication is intended for direct administration and therefore requires strict sterility standards to prevent infection and contamination.

The recalled product has lot number 08182021:00 with a beyond-use date of 12/16/2021, and was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Consumers who have received this medication should contact their healthcare provider or pharmacist immediately. Do not use the recalled vials. Healthcare providers and patients should return the product to the pharmacy or manufacturer for proper disposal.

The recalled product

Product: BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Manufacturer: Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category: Drug — Injectable / Compounded Pharmacy
Hazard: lack-of-sterility
injectable-contamination
infection-risk
Affected units: 1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot: 08182021:00 BUD: 12/16/2021

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 130 products in this recall →

Same manufacturer · Vita Pharmacy, LLC dba Talon Compounding Pharmacy

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