TRI-MIX Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
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 compounded injectable product with lack of sterility assurance, a critical safety defect in parenteral medications that carries significant risk of serious infection and potential hospitalization. The hazard involves direct patient administration of a potentially contaminated preparation.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML injectable (Rx only) due to lack of assurance of sterility. The recall affects one vial, lot 06012021:18, with a beyond-use date of 10/23/2021.
This product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Non-sterile injectable products may introduce microorganisms that could cause serious infection if administered.
Patients who have received this product should consult their healthcare provider. Healthcare providers and patients with questions or concerns should contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 1
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 (1)
- Lot: 06012021:18 BUD: 10/23/2021
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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