Tri-Mix Papaverine Injectable Lacks Sterility Assurance
Talon Compounding Pharmacy is recalling a lot of Tri-Mix Papaverine injectable due to lack of assurance of sterility. The recalled product is distributed across the United States.
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 injectable product. Loss of sterility assurance in an injectable drug poses risk of serious infection or other serious adverse health consequences, and injectable products are high-risk when sterility cannot be assured.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling lot 05192021:49 (BUD 10/23/2021) of Tri-Mix Papaverine 30/Phentolamine 4/PGE-1 5 injectable because the manufacturer cannot assure the product's sterility.
The recalled product is a prescription injectable medication distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Consumers who have received this medication should contact their healthcare provider or pharmacist for guidance on next steps. Healthcare providers and patients should not use the recalled lot.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 5 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 — Injectable / Compounded
- Hazard
- lack-of-sterility
- contamination-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: 05192021:49 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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