TRI-MIX Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 injectable vials distributed nationwide due to lack of assurance of sterility.
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 a sterile injectable pharmaceutical product. Lack of sterility assurance in injectable medications poses a significant risk of serious infection or sepsis, which can result in hospitalization or severe harm, meeting the Severe classification criterion.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247, is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 injectable (3 vials per package) because the manufacturer cannot assure the product's sterility.
The affected product was distributed in the United States, including Washington, D.C. and Puerto Rico. The recalled lots are: Lot 07162021:14 with a Beyond Use Date (BUD) of 11/30/2021, and Lot 09142021:63 with a BUD of 02/08/2022.
Patients who have received this injectable or healthcare providers who have dispensed it should consult with their physician or pharmacist regarding appropriate follow-up care. The product is a prescription-only medication.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 INJ **ST 1** 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
- sterility-assurance
- injection-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: 07162021:14 BUD: 11/30/2021
- 09142021:63 BUD: 02/08/2022
Distribution
Distribution scope not specified by the agency.
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