The Recall Desk
SevereFDA (Drugs)·D-0206-2022·Announced 2021-11-17

TRI-MIX PAPAVERINE injectable recalled for lack of sterility assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling 22 vials of TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 injectable due to lack of assurance of sterility. The product was distributed across the United States including Washington, D.C. and Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. Sterility assurance failures in injectable drugs represent a significant risk of harm—contaminated injectables can cause serious infections and other adverse events. Although no illnesses are reported in the source text, the nature of the defect and the injection route warrant a Severe classification.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 injectable (22 vials total) because the firm cannot assure that the product meets sterility requirements.

The affected product has five lot numbers: 07142021:91 (BUD 10/23/2021), 08122021:46 (BUD 02/08/2022), 07092021:88 (BUD 10/23/2021), 08022021:45 (BUD 11/30/2021), and 09082021:46 (BUD 02/08/2022). The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Consumers who have this product should contact their healthcare provider or pharmacy. Healthcare providers and patients should not use the recalled product.

The recalled product

Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/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 — Injectable / Compounded
Hazard
  • sterility-assurance
  • injectable-contamination

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: 07142021:91 BUD: 10/23/2021
  • 08122021:46 BUD: 02/08/2022
  • 07092021:88 BUD: 10/23/2021
  • 08022021:45 BUD: 11/30/2021
  • 09082021:46 BUD: 02/08/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

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