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.
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 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
- 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: 07072021:20 BUD: 10/23/2021
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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