Tri-Mix Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 18/Phentol 0.6/PGE-1 5.88/ML 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 drug recall involving a sterility assurance defect in an injectable pharmaceutical. Injectable products lacking sterility assurance pose significant risk of serious infection and warrant hospitalization-level harm, meeting the Severe criteria.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 18/Phentol 0.6/PGE-1 5.88/ML Injectable (Rx only) distributed from its facility at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247. The recall is due to lack of assurance of sterility.
The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Two vials with the following lot numbers and beyond-use dates are included: Lot 08062021:45 with BUD 11/30/2021, and Lot 07132021:75 with BUD 10/23/2021.
Patients and healthcare providers who have received or dispensed this product should discontinue use immediately and consult their healthcare provider regarding potential exposure.
The recalled product
- Product
- TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 5.88/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 Pharmaceutical
- Hazard
- sterility-assurance
- contamination-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: 08062021:45 BUD: 11/30/2021
- 07132021:75 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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