TRI-MIX PAPAVERINE Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ injectable vials 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA has classified this as a Class II recall. The source states only a lack of assurance of sterility without reporting any actual illnesses or injuries, making this a precautionary recall rather than one with confirmed harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ, an injectable pharmaceutical product distributed in the United States including Washington, D.C. and Puerto Rico. The recall was initiated due to lack of assurance of sterility.
The affected product consists of 8 vials with the following lot and beyond-use dates: Lot 06232021:01 (BUD 10/23/2021) and Lot 08132021:58 (BUD 02/08/2022). The product was manufactured and distributed by Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
Patients who have received this product should consult their healthcare provider if they have any health concerns related to its use. Healthcare providers should direct questions about the recall to Talon Compounding Pharmacy.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 8
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: 06232021:01 BUD: 10/23/2021
- 08132021:58 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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