Tri-Mix Injectable Lacks Sterility Assurance, Compounding Pharmacy Recall
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine/Phentolamine/PGE-1 injectable due to lack of assurance of sterility. The product was distributed across 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: This is an FDA Class II injectable pharmaceutical recall involving sterility defects. Lack of sterility assurance in injectables poses a significant risk of serious infection and adverse health effects, meeting the Severe classification criterion for FDA Class II recalls with potential for serious harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25 in San Antonio, Texas, is recalling Tri-Mix Papaverine 30/Phentolamine 0.5/PGE-1 40/mL Injectable (Rx only) due to lack of assurance of sterility.
The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lot is 08092021:52 with a beyond-use date of 11/30/2021.
Patients currently using this product should consult their healthcare provider before discontinuing use. Healthcare providers with questions about this recall may contact the pharmacy directly.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 40 /ML 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-defect
- infection-risk
- 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: 08092021:52 BUD: 11/30/2021
Distribution
Distribution scope not specified by the agency.
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