Quad-Mix Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Quad-Mix Papav 30/Phentol 2/PGE-1 30/Atropine 0.2 injectable medication due to lack of assurance of sterility. The product was distributed throughout 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 involving a sterility defect in an injectable drug product. Lack of sterility assurance in injectable medications poses a significant risk of serious infection or other adverse health consequences, meeting the Severe classification criteria.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Quad-Mix Papav 30/Phentol 2/PGE-1 30/Atropine 0.2 injectable medication in vials. The recall was initiated because of lack of assurance of sterility.
The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The recalled lots include: Lot 08182021:31 with Beyond Use Date 02/08/2022; Lot 08262021:69 with Beyond Use Date 02/08/2022; and Lot 08052021:40 with Beyond Use Date 11/30/2021.
Consumers who have received this medication should contact their healthcare provider or pharmacist for guidance. The product should not be used.
The recalled product
- Product
- QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 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
- sterility-defect
- contamination-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 (3)
- Lot: 08182021:31 BUD: 02/08/2022
- 08262021:69 BUD: 02/08/2022
- 08052021:40 BUD: 11/30/2021
Distribution
Distribution scope not specified by the agency.
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