TRI-MIX Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 injectable medication because the manufacturer cannot assure sterility of the product. The recall affects one lot distributed across the United States, Washington, D.C., and Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile injectable medication where sterility cannot be assured. Lack of sterility in injectable products poses significant risk of serious infection or sepsis and meets the Severe criterion for FDA Class II recalls.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 injectable medication due to lack of assurance of sterility. The product is a prescription-only injectable compounded medication manufactured at the company's location in San Antonio, Texas.
The recall affects Lot 04222021:98 with a beyond-use date of 10/19/2021. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Consumers who have received this medication should contact their healthcare provider for guidance. Healthcare providers should stop dispensing this product and return remaining inventory to Vita Pharmacy, LLC dba Talon Compounding Pharmacy.
The recalled product
- Product
- TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- 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: 04222021:98 BUD: 10/19/2021
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 · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighTriMix Injection Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighTriMix Injectable Medication Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighTriMix Injection Recall Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighInjectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- HighTriMix Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-01-18
- HighPharmacy Compounded Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09