Tri-Mix Papaverine Injection Recalled Due to Sterility Assurance Lack
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 15/Phentolamine 1/PGE-1 10 injectable vials due to lack of assurance of sterility. The affected lot (09082021:40, BUD 02/08/2022) was distributed throughout the United States including 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 of a sterile injectable drug product. Lack of sterility assurance in injectable medications poses a serious risk of infection and potential hospitalization, meeting the Severe criteria for Class II recalls with significant injury/illness risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 15/Phentolamine 1/PGE-1 10 injectable vials (Rx only) due to lack of assurance of sterility. The recalled lot number is 09082021:40 with a beyond-use date of 02/08/2022.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The pharmacy is located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
Consumers and healthcare providers who have received this product should not use it. Patients who have received injections from the recalled vials should consult their healthcare provider immediately if they experience any signs of infection or unusual symptoms.
The recalled product
- Product
- TRI-MIX PAPAVERINE 15/PHENTOLAMINE 1/PGE-1 10 INJ 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: 09082021:40 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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