The Recall Desk
SevereFDA (Drugs)·D-0194-2022·Announced 2021-11-17

Tri-Mix Papaverine Injectable from Talon Compounding Pharmacy Recalled

Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 23.3/Phentolamine 1/PGE-1 12 INJ due to lack of assurance of sterility. The product was distributed across the United States, 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 recall is classified as FDA Class II and involves a sterile injectable product lacking assurance of sterility, which creates a direct risk of serious infection. Injectable products lacking sterile assurance present significant potential for harm and meet the Severe classification threshold.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 23.3/Phentolamine 1/PGE-1 12 INJ (injectable, Rx only) due to lack of assurance of sterility. The affected lot is 08102021:71 with a beyond-use date of 11/30/2021.

The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Consumers or healthcare providers who have received this medication should not use it and should contact their healthcare provider or pharmacist for guidance on proper disposal and replacement therapy.

The recalled product

Product
TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 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
  • lack-of-sterility
  • 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: 08102021:71 BUD: 11/30/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

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