Tri-Mix Papaverine Injectable from Talon Compounding Pharmacy Recalled
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 23.3/Phentolamine 1/PGE-1 12 INJ 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 recall is classified as FDA Class II and involves a sterile injectable product lacking assurance of sterility, which creates a direct risk of serious infection. Injectable products lacking sterile assurance present significant potential for harm and meet the Severe classification threshold.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 23.3/Phentolamine 1/PGE-1 12 INJ (injectable, Rx only) due to lack of assurance of sterility. The affected lot is 08102021:71 with a beyond-use date of 11/30/2021.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Consumers or healthcare providers who have received this medication should not use it and should contact their healthcare provider or pharmacist for guidance on proper disposal and replacement therapy.
The recalled product
- Product
- TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- 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: 08102021:71 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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