Tri-Mix Injectable Lacks Sterility Assurance, Compounding Pharmacy Recall
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine/Phentolamine/PGE-1 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 injectable pharmaceutical recall involving sterility defects. Lack of sterility assurance in injectables poses a significant risk of serious infection and adverse health effects, meeting the Severe classification criterion for FDA Class II recalls with potential for serious harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25 in San Antonio, Texas, is recalling Tri-Mix Papaverine 30/Phentolamine 0.5/PGE-1 40/mL Injectable (Rx only) due to lack of assurance of sterility.
The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lot is 08092021:52 with a beyond-use date of 11/30/2021.
Patients currently using this product should consult their healthcare provider before discontinuing use. Healthcare providers with questions about this recall may contact the pharmacy directly.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 40 /ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 1
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: 08092021:52 BUD: 11/30/2021
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
Same manufacturer · Vita Pharmacy, LLC dba Talon Compounding Pharmacy
See all →- HighInjectable testosterone and dutasteride product recall for sterility assurance failure
FDA (Drugs) · 2021-11-17
- HighIC B Complex Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- SevereTRI-MIX Injectable by Talon Compounding Pharmacy Recalled for Sterility Assurance
FDA (Drugs) · 2021-11-17
- SevereInjectable Steroid Combination Product Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- HighTestosterone Bi-Blend Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
Same hazard · sterility defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- HighMedline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
FDA (Devices) · 2026-05-06