Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 1/PGE-1 2.5 injectable due to lack of assurance of sterility. The recall affects 30 vials distributed across the United States.
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: The FDA classified this as a Class II recall. The hazard—lack of sterility assurance in an injectable medication—poses a significant risk of serious harm including infection or sepsis if the product was used. Although no reported illnesses are stated in the source, the nature of a non-sterile injectable meets the Severe threshold for a Class II recall with inherent risk of serious injury.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 1/PGE-1 2.5 injectable (prescription only) manufactured at their facility in San Antonio, Texas. The recall is due to lack of assurance of sterility.
The affected product consists of 30 vials distributed throughout the United States, including Washington, D.C. and Puerto Rico. Five specific lots have been identified: Lot 07222021:11 (expiration 11/30/2021), Lot 08172021:72 (expiration 02/08/2022), Lot 06282021:84 (expiration 10/23/2021), Lot 07132021:93 (expiration 10/23/2021), and Lot 09102021:43 (expiration 02/08/2022).
Consumers or healthcare providers who have this product should discontinue use and contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy for further instructions.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 30
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: 07222021:11 BUD: 11/30/2021
- 08172021:72 BUD: 02/08/2022
- 06282021:84 BUD: 10/23/2021
- 07132021:93 BUD: 10/23/2021
- 09102021:43 BUD: 02/08/2022
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 assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- HighTriMix Injection Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighTriMix Injection Recalled Due to Sterility Assurance Failure
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
- HighTriMix Injection Recalled 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