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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Injectable / Compounded
- Affected units
- 1
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
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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