TRI-MIX PAPAVERINE Injectable Recall: Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ due to lack of assurance of sterility. The affected lot 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source indicates an FDA Class II recall of a sterile injectable product with lack of assurance of sterility, which poses a risk of serious harm (infection). The source text does not report any illnesses or injuries, making this a risk-of-harm situation without reported adverse outcomes, consistent with a High (score 3) severity classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ, a prescription injectable medication, due to lack of assurance of sterility.
The recalled product is an injectable formulation manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. The affected lot is 07192021:30 with a beyond-use date (BUD) of 01/15/2022.
The product was distributed throughout the United States, including Washington D.C. and Puerto Rico. Patients who have received doses from this lot should consult their healthcare provider. Consult with a physician or pharmacist before discarding any medication.
The recalled product
- Product
- TRI-MIX PAPAVERINE 40/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
- 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: 07192021:30 BUD: 01/15/2022
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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