TRI-MIX Papaverine Injectable Recalled for Sterility Assurance Failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 injectable medication due to lack of assurance of sterility.
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. Non-sterile injectables present serious risk of infection and systemic infection, which can result in hospitalization. Per the severity rubric, Class II recalls with serious inherent risks of harm meet the Severe (4) threshold.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25 in San Antonio, Texas, is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 injectable medication. The recall affects 2 vials with lot numbers 05142021:17 (BUD: 10/23/2021) and 08062021:79 (BUD: 02/02/2022).
The medication is being recalled due to lack of assurance of sterility. This is a prescription-only injectable product that was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Patients who have received this medication should contact their healthcare provider for guidance. Healthcare providers and patients with questions should contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 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
- non-sterile-injectable
- 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 (2)
- Lot: 05142021:17 BUD: 10/23/2021
- 08062021:79 BUD: 02/02/2022
Distribution
Distribution scope not specified by the agency.
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