TRI-MIX Papaverine Injectable from Talon Compounding Pharmacy Recalled
Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML injectable medication 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 an injectable drug with a sterility defect. Non-sterile injectables carry high risk of serious infection and potential hospitalization, meeting the Severe criterion even absent reported illness.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML INJ, an injectable prescription medication, due to lack of assurance of sterility. The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
The affected lot number is 08062021:09, with a beyond-use date of 11/30/2021. Consumers or healthcare providers who have received this medication should not use it and should contact their pharmacy or healthcare provider for guidance.
Non-sterile injectable medications pose a serious risk of infection. Patients who have received doses of this product should consult their healthcare provider if they experience symptoms of infection at the injection site or systemically.
The recalled product
- Product
- TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML 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
- 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 (1)
- Lot: 08062021:09 BUD: 11/30/2021
Distribution
Distribution scope not specified by the agency.
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