Quad-Mix Injectable Compound Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication (Quad-Mix Papav 30/Phentol 1/PGE-1 10/Atropine 0.15) due to lack of assurance of sterility. The affected lot was distributed across the United States, 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 compounded injectable drug with a sterility defect. Injectable products that lack sterility assurance pose a serious risk of infection and serious injury or hospitalization, meeting the Class II with serious injury risk criterion.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Quad-Mix Papav 30/Phentol 1/PGE-1 10/Atropine 0.15 Injectable due to lack of assurance of sterility. The recalled product is a prescription-only injectable compound.
The affected lot is 07072021:20 with a beyond-use date of 10/23/2021. This product was distributed across the United States, including Washington, D.C., and Puerto Rico.
Patients who have received this medication should contact their healthcare provider. Healthcare providers should consult FDA guidance on appropriate management of patients who received this product.
The recalled product
- Product
- QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility
- contamination-risk
- infection-risk
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: 07072021:20 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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