TRI-MIX Papaverine/Phentolamine/PGE-1 Injectable Recalled for Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 injectable vials due to lack of assurance of sterility. The recalled 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 sterile compounded injectable product. Lack of sterility assurance in injectable medications poses a serious risk of infection; the agency's own classification places this in the Severe category per the rubric.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 injectable (Rx only) due to lack of assurance of sterility. The recalled product consists of 4 vials identified by lot numbers 07272021:15 (beyond use date 11/30/2021) and 07122021:11 (beyond use date 10/23/2021).
The product was distributed nationwide, including Washington, D.C. and Puerto Rico. Because this is a compounded injectable medication lacking sterility assurance, there is a potential risk of serious infection to patients who receive it.
Patients who have received this product should consult their healthcare provider immediately if they experience any signs or symptoms of infection. Healthcare providers should not dispense or administer the recalled product.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 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
- sterility-assurance
- infection-risk
- compounding-defect
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: 07272021:15 BUD: 11/30/2021
- 07122021:11 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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