Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of Tri-Mix Papaverine 15/Phentolamine 2/PGE-1 20 Injectable due to lack of assurance of sterility. The recalled product was distributed throughout 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 recall of a sterile injectable drug product. Lack of sterility assurance in an injectable medication poses a significant risk of serious infection and potential hospitalization, meeting the Severe classification criterion for FDA Class II with inherent serious-injury risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 15/Phentolamine 2/PGE-1 20 Injectable, a prescription injectable medication. The recall affects one vial with Lot 09132021:55 and BUD (Beyond Use Date) of 02/08/2022. The recall was issued because the firm cannot assure the product meets sterility requirements.
The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this medication should consult their healthcare provider immediately.
The recalled product
- Product
- TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/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-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 (1)
- Lot: 09132021:55 BUD: 02/08/2022
Distribution
Distribution scope not specified by the agency.
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