TRI-MIX PAPAVERINE Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 injectable due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.
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: The FDA classified this as a Class II recall. Loss of sterility assurance in an injectable drug poses a serious risk of infection and potential hospitalization, which meets the Severe criteria for Class II recalls with risk of serious harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one vial of TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 injectable, an Rx-only compounded injectable medication. The recall is due to lack of assurance of sterility.
The affected product (Lot 07282021:66 with beyond-use date of 11/30/2021) was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Consumers who have received this product should consult with their healthcare provider or pharmacist regarding potential exposure. Healthcare providers should also be aware of this recall and review patient records for any adverse events.
The recalled product
- Product
- TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- 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: 07282021:66 BUD: 11/30/2021
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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