The Recall Desk
SevereFDA (Drugs)·D-0205-2022·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 1/PGE-1 2.5 injectable due to lack of assurance of sterility. The recall affects 30 vials distributed across the United States.

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: The FDA classified this as a Class II recall. The hazard—lack of sterility assurance in an injectable medication—poses a significant risk of serious harm including infection or sepsis if the product was used. Although no reported illnesses are stated in the source, the nature of a non-sterile injectable meets the Severe threshold for a Class II recall with inherent risk of serious injury.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 1/PGE-1 2.5 injectable (prescription only) manufactured at their facility in San Antonio, Texas. The recall is due to lack of assurance of sterility.

The affected product consists of 30 vials distributed throughout the United States, including Washington, D.C. and Puerto Rico. Five specific lots have been identified: Lot 07222021:11 (expiration 11/30/2021), Lot 08172021:72 (expiration 02/08/2022), Lot 06282021:84 (expiration 10/23/2021), Lot 07132021:93 (expiration 10/23/2021), and Lot 09102021:43 (expiration 02/08/2022).

Consumers or healthcare providers who have this product should discontinue use and contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy for further instructions.

The recalled product

Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 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-assurance
  • contamination-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 (5)

  • Lot: 07222021:11 BUD: 11/30/2021
  • 08172021:72 BUD: 02/08/2022
  • 06282021:84 BUD: 10/23/2021
  • 07132021:93 BUD: 10/23/2021
  • 09102021:43 BUD: 02/08/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

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