Talon Compounding Pharmacy Quad-Mix Injectable Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 injectable due to lack of assurance of sterility. The affected product was distributed in 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 sterile injectable product with compromised sterility assurance. Injectable products without assured sterility pose a significant risk of serious infection and adverse outcomes to patients, meeting the Severe criteria for Class II recalls with risk of harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 INJ INJECTABLE, Rx only, from 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. The recall affects lot 08052021:10 with a Beyond Use Date (BUD) of 11/30/2021. The product is being recalled due to lack of assurance of sterility.
The affected injectable was distributed throughout the United States including Washington, D.C. and Puerto Rico. Patients who have received this product should consult with their healthcare provider about the potential risks and whether they need further medical evaluation. Healthcare providers and patients should not use the affected lot and should return it to the pharmacy.
The recalled product
- Product
- QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 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: 08052021:10 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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