TRI-MIX Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX Papaverine 30/Phentolamine 2/PGE-1 30 injectable due to lack of assurance of sterility. The product was distributed in the United States, including 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving lack of sterility assurance in a sterile injectable product—a high-risk hazard category. The source text does not report any illnesses or injuries, so per the rubric the score is at most 3, but lack of sterility in an injectable is a risk-of-harm product that warrants High severity.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX Papaverine 30/Phentolamine 2/PGE-1 30 injectable due to lack of assurance of sterility. The recalled product includes 7 vials with lot numbers 06252021:81 (BUD 10/23/2021) and 09102021:09 (BUD 02/08/2022).
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this injectable should contact their healthcare provider for guidance.
Consumers and healthcare providers who have received this product should stop using it immediately and contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy or the FDA with any questions or if adverse reactions occur.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 7
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: 06252021:81 BUD: 10/23/2021
- 09102021:09 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.
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