TRI-MIX Injectable by Talon Compounding Pharmacy Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling TRI-MIX injectable medication because the manufacturer cannot assure that the product meets sterility requirements. Affected patients should consult their healthcare provider immediately.
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 an injectable drug with a sterility defect. Lack of sterility assurance in injectable medications presents a significant risk of serious infection and hospitalization, meeting the Severe criteria for Class II recalls with risk of serious injury.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling TRI-MIX PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/ML INJ, a prescription injectable medication, due to lack of assurance of sterility.
The recall affects two vials with the following lot information: Lot 07092021:15 with a beyond-use date of 10/23/2021, and Lot 08182021:65 with a beyond-use date of 02/08/2022. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Non-sterile injectable medication poses a serious health risk to patients who receive it. Patients who have received this medication should contact their healthcare provider immediately to discuss their exposure and any potential health effects.
The recalled product
- Product
- TRI-MIX PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/ML 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
- sterility-failure
- infection-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 (2)
- Lot: 07092021:15 BUD: 10/23/2021
- 08182021:65 BUD: 02/08/2022
Distribution
Distribution scope not specified by the agency.
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