TRI-MIX Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 injectable medication because the manufacturer cannot assure sterility of the product. The recall affects one lot 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 is an FDA Class II recall involving a sterile injectable medication where sterility cannot be assured. Lack of sterility in injectable products poses significant risk of serious infection or sepsis and meets the Severe criterion for FDA Class II recalls.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 injectable medication due to lack of assurance of sterility. The product is a prescription-only injectable compounded medication manufactured at the company's location in San Antonio, Texas.
The recall affects Lot 04222021:98 with a beyond-use date of 10/19/2021. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Consumers who have received this medication should contact their healthcare provider for guidance. Healthcare providers should stop dispensing this product and return remaining inventory to Vita Pharmacy, LLC dba Talon Compounding Pharmacy.
The recalled product
- Product
- TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 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
- microbial-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: 04222021:98 BUD: 10/19/2021
Distribution
Distribution scope not specified by the agency.
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