TRI-MIX Injectable Compounded Drug Recalled for Sterility Assurance Failure
Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 injectable medication due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterility defect in an injectable pharmaceutical product. Sterility assurance failures in injectable drugs present direct risk of serious infection and other severe harm upon administration, meeting the Class II with significant-injury-risk criterion.
Plain-English summary
Talon Compounding Pharmacy, located in San Antonio, Texas, is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 INJECTABLE due to lack of assurance of sterility. The product is a prescription-only injectable medication.
The recall affects lot 07232021:18 with a beyond-use date (BUD) of 11/30/2021. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Injectable medications that lack assured sterility present a risk of infection and other serious complications when administered to patients. Consumers or healthcare providers who have this product should discontinue use and consult with their healthcare provider or pharmacist regarding alternative treatment options.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 INJ**T 106** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 1
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: 07232021:18 BUD: 11/30/2021
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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