TRI-MIX Papaverine Injectable Recalled Due to Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 injectable due to lack of 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 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 of a sterile injectable product with lack of sterility assurance, which poses a serious risk of infection and harm. Class II recalls involving injectable medications and potential for patient harm warrant a Severe rating.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ (**T 101**) injectable medication. The recall is for lot 07262021:32 with a beyond-use date (BUD) of 11/30/2021.
The reason for the recall is lack of assurance of sterility. This product is a prescription-only injectable compounded by Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Patients who have this medication should contact their healthcare provider or pharmacist for guidance. Do not use the recalled product without consulting with a healthcare professional.
The recalled product
- Product
- TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ **T 101** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- 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: 07262021:32 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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