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.
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: 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
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- injectable-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: 07282021:66 BUD: 11/30/2021
Distribution
Distribution scope not specified by the agency.
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