The Recall Desk
SevereFDA (Drugs)·D-0204-2022·Announced 2021-11-17

Tri-Mix Injectable Compounded Drug Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine/Phentolamine/PGE-1 injectable vials distributed across the United States and Puerto Rico due to lack of assurance of sterility.

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 sterility assurance failure for an injectable compounded drug. Loss of sterility assurance in parenteral medications poses a risk of serious infections and health complications, meeting the Class II severe designation criteria.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 12 INJ, a prescription injectable drug compounded at their facility located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. The recall affects 13 vials distributed throughout the United States, including Washington, D.C. and Puerto Rico.

The recall was initiated due to lack of assurance of sterility. The affected lot numbers are 07092021:34 (BUD 10/23/2021); 08302021:33 (BUD 02/08/2022); 08162021:08 (BUD 02/08/2022); 08262021:31 (BUD 02/08/2022); and 09152021:63 (BUD 02/08/2022).

Patients who have received this product should consult with their healthcare provider. Healthcare providers and patients are encouraged to report any adverse effects or concerns related to this product to the FDA.

The recalled product

Product
TRI-MIX PAPAVERINE 30/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
  • sterility-assurance-failure
  • 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: 07092021:34 BUD: 10/23/2021
  • 08302021:33 BUD: 02/08/2022
  • 08162021:08 BUD: 02/08/2022
  • 08262021:31 BUD: 02/08/2022
  • 09152021:63 BUD: 02/08/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category