Talon Compounding Pharmacy injectable lacks sterility assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication (QUAD-MIX) due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. 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 medication. Loss of sterility assurance in a parenteral (injection) product poses a significant risk of serious infection and other adverse health effects, justifying a Severe classification per the rubric for Class II recalls with inherent serious-injury risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6*, an injectable compounded medication, distributed across the United States, including Washington, D.C. and Puerto Rico. The product is available by prescription only and was manufactured by Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
The recall is issued because the pharmacy lacks assurance of sterility for this product. The affected lot is Lot 07192021:52, with a beyond-use date (BUD) of 11/30/2021.
Patients who have received this product should consult their healthcare provider immediately. Healthcare providers should not dispense this product and should consider notifying patients who may have received it. The FDA is overseeing this Class II recall.
The recalled product
- Product
- QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* 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: 07192021:52 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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