The Recall Desk
HighFDA (Drugs)·D-0217-2022·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 3/PGE-1 30 injectable due to lack of assurance of sterility. The product was distributed across the United States.

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 a sterile injectable drug product. Lack of sterility assurance in an injectable medication represents a significant risk of harm (infection, contamination) to users. The source text does not report any illnesses or injuries to date, placing this at the upper end of High per the rubric.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 3/PGE-1 30 injectable (Lot: 06282021:57, BUD: 10/23/2021) due to lack of assurance of sterility. This is a prescription-only injectable medication.

The affected product was distributed across the United States, including Washington, D.C. and Puerto Rico.

Consumers who have received this product should contact their healthcare provider or Vita Pharmacy, LLC dba Talon Compounding Pharmacy for guidance. Patients should not use the product without consulting their healthcare provider.

The recalled product

Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 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 Medication
Hazard
  • lack-of-sterility
  • contamination-risk
  • infection-risk

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: 06282021:57 BUD: 10/23/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

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