The Recall Desk
HighFDA (Drugs)·D-0220-2022·Announced 2021-11-17

Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 4/PGE-1 20 injectable due to lack of assurance of sterility. The recall affects 13 vials distributed across the United States, Washington, D.C., and Puerto Rico.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with a sterility defect. Although no illnesses or injuries are explicitly reported in the source text, lack of sterility assurance in an injectable medication presents a significant risk of harm (infection, sepsis, other serious complications) to patients who receive it. The hazard is not merely theoretical—the product lacks documented sterile conditions—placing this at High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 4/PGE-1 20 injectable (Rx only) due to a lack of assurance of sterility. The recall involves 13 vials.

The affected product was manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. The recalled lots include Lot 06232021:24 (BUD 10/23/2021), Lot 07192021:69 (BUD 01/15/2022), Lot 09132021:87 (BUD 03/12/2022), Lot 07282021:91 (BUD 01/24/2022), and Lot 04162021:06 (BUD 10/13/2021).

Distribution of the recalled product extended across the United States, including Washington, D.C. and Puerto Rico. Patients and healthcare providers who have received this product should consult with the prescribing physician regarding appropriate next steps.

The recalled product

Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 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 — Compounded Injectable
Hazard
  • sterility-defect
  • injection-safety

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 (5)

  • Lot: 06232021:24 BUD: 10/23/2021
  • 07192021:69 BUD: 01/15/2022
  • 09132021:87 BUD: 03/12/2022
  • 07282021:91 BUD: 01/24/2022
  • 04162021:06 BUD: 10/13/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

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