TRI-MIX Injectable Compounded Drug Recalled for Sterility Assurance Failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 injectable medication due to lack of assurance of sterility. The recall affects vials distributed throughout 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: This is an FDA Class II recall of a sterile injectable pharmaceutical product. Class II recalls involve serious health risks with potential for hospitalization; injectable medications with sterility failures present significant risk of infection and adverse effects, meeting the Severe threshold.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 injectable medication (Rx only) due to lack of assurance of sterility. The affected product consists of 4 vials distributed throughout the United States, including Washington, D.C. and Puerto Rico.
The specific lots under recall are Lot 07082021:16 with BUD 10/23/2021 and Lot 08172021:26 with BUD 02/08/2022, distributed from Talon Compounding Pharmacy located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
Patients who have received this medication should contact their healthcare provider. The FDA classified this as a Class II recall. Healthcare providers and patients should discontinue use of affected lots and consult their prescriber regarding alternative treatment options.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 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-failure
- injectable-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 (2)
- Lot: 07082021:16 BUD: 10/23/2021
- 08172021:26 BUD: 02/08/2022
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateEstradiol Gel Packets Recalled for Empty or Partially Full Containers
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27