Tri-Mix Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 18/Phentol 0.6/PGE-1 5.88/ML Injectable due to lack of assurance of sterility. The product was distributed across 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 drug recall involving a sterility assurance defect in an injectable pharmaceutical. Injectable products lacking sterility assurance pose significant risk of serious infection and warrant hospitalization-level harm, meeting the Severe criteria.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 18/Phentol 0.6/PGE-1 5.88/ML Injectable (Rx only) distributed from its facility at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247. The recall is due to lack of assurance of sterility.
The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Two vials with the following lot numbers and beyond-use dates are included: Lot 08062021:45 with BUD 11/30/2021, and Lot 07132021:75 with BUD 10/23/2021.
Patients and healthcare providers who have received or dispensed this product should discontinue use immediately and consult their healthcare provider regarding potential exposure.
The recalled product
- Product
- TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 5.88/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable Pharmaceutical
- Affected units
- 2
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: 08062021:45 BUD: 11/30/2021
- 07132021:75 BUD: 10/23/2021
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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