TRI-MIX Injectable Medication Recalled Due to Sterility Assurance Failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ injectable medication because the manufacturer lacks assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable product where sterility assurance has failed. Although no illnesses or injuries have been reported in the source text, a lack of sterility in injectable medications poses a significant risk of serious harm including infection; this meets the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ, an injectable prescription medication, due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.
The affected lots are 06252021:69 with a beyond-use date of 10/23/2021 and lot 08272021:62 with a beyond-use date of 02/08/2022. The recalled product consists of 5 vials per package manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
Patients who have received this medication should contact their healthcare provider for guidance. Healthcare providers should quarantine remaining stock and consult with the pharmacy regarding appropriate next steps.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 5
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: 06252021:69 BUD: 10/23/2021
- 08272021:62 BUD: 02/08/2022
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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