TRI-MIX Injectable Compounded Drug Lacks Assured Sterility
Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 injectable vials because the manufacturer cannot assure sterility of the product.
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 drug recall involving a sterility defect in an injectable compounded medication. Injectable products with compromised sterility present a significant risk of serious infection and may require hospitalization, meeting the Class II with risk-of-serious-injury criterion.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 INJ injectable medication (Rx only) distributed from their San Antonio, Texas location. The recall affects 4 vials with lot number 06252021:39 (BUD 10/23/2021) and lot number 08132021:31 (BUD 02/08/2022).
The product is being recalled due to lack of assurance of sterility. Non-sterile injectable products pose a risk of infection to patients who receive the medication.
The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received doses of this medication should contact their healthcare provider. Healthcare providers with existing inventory should stop dispensing the product and contact the pharmacy for instructions.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 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
- lack-of-sterility
- infection-risk
- 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: 06252021:39 BUD: 10/23/2021
- 08132021:31 BUD: 02/08/2022
Distribution
Distribution scope not specified by the agency.
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