Tri-Mix Injectable Lacks Sterility Assurance, Compounded Medication Recalled
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable medication because the manufacturer cannot guarantee sterility. The affected injectable product was distributed across 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 an injectable medication where sterility cannot be assured. Non-sterile injectable products pose a direct risk of serious infection (sepsis, endocarditis, meningitis) even without reported illnesses to date, meeting the threshold for Severe classification.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling Tri-Mix Papaverine 30/Phentolamine 4/PGE-1 60 INJ, an injectable prescription medication, because the manufacturer lacks assurance of sterility.
The recalled product consists of 3 vials with lot numbers 07062021:22 (expiration 10/23/2021) and 08262021:81 (expiration 02/22/2022). The medication was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Patients who have received this injectable medication should contact their healthcare provider. Healthcare providers who dispensed this product should quarantine remaining stock and contact the pharmacy at the address listed on the product for further instructions.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 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
- Category
- Drug — Compounded Injectable
- Hazard
- contamination-microbial
- lack-of-sterility
- infection-risk
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: 07062021:22 BUD: 10/23/2021
- 08262021:81 BUD: 02/22/2022
Distribution
Distribution scope not specified by the agency.
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