The Recall Desk
SevereFDA (Drugs)·D-0201-2022·Announced 2021-11-17

TRI-MIX PAPAVERINE Injectable from Talon Compounding Pharmacy Recalled

Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 injectable medication 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 of a sterile injectable compounded drug. Lack of sterility assurance in injectable products poses a serious risk of infection and requires hospitalization or medical intervention, meeting the Class II with serious-hazard criterion for a Severe rating.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 INJ, an injectable prescription medication. The recall applies to product Lot 06252021:22 with a beyond-use date of 10/23/2021.

The product is being recalled due to lack of assurance of sterility. This compounded injectable medication was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Patients who have received this product should contact their healthcare provider. Healthcare providers should review patient records and report any adverse events to the FDA.

The recalled product

Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/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
Hazard
  • sterility-assurance
  • infection-risk
  • 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 (1)

  • Lot: 06252021:22 BUD: 10/23/2021

Distribution

Distribution scope not specified by the agency.