Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable due to lack of assurance of sterility. The product was distributed across the United States, 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 recall is classified as FDA Class II. Lack of sterility assurance in an injectable medication represents a significant risk of harm, as non-sterile injectables can cause serious infections and complications, warranting a Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 0.25/PGE-1 6 Injectable, a prescription medication, due to lack of assurance of sterility.
The recalled product is identified as lot 06162021:93 with a beyond-use date of 10/23/2021. It was distributed throughout the United States, including Washington D.C. and Puerto Rico.
Consumers who have received this medication should consult with their healthcare provider regarding their use of the product. Healthcare providers with questions about the recall should contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy at the address listed: 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.25/PGE-1 6 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
- Hazard
- sterility-failure
- 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 (1)
- Lot: 06162021:93 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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