Tri-Mix Papaverine Injectable Vials Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable vials due to lack of assurance of sterility. The product was distributed in 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 sterile injectable pharmaceutical product. Lack of sterility assurance in injectable medications poses a serious risk of infection and meets the Severe criteria because injectable products with sterility defects require urgent clinical intervention and carry heightened risk of hospitalization.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling Tri-Mix Papaverine 30/Phentolamine 2/PGE-1 20 injectable vials (lot numbers 07192021:23, 08032021:21, 04282021:39, and 06102021:69) because the manufacturer cannot assure sterility of the product.
The affected vials were distributed throughout the United States, including Washington D.C. and Puerto Rico. A total of 22 vials have been recalled.
Consumers who have received this medication should consult their healthcare provider immediately. Do not use the product. The medication should be returned to Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 20 INJ **T 104** 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
- injectable-contamination
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 (4)
- Lot: 07192021:23 BUD: 01/15/2022
- 08032021:21 BUD: 01/30/2022
- 04282021:39 BUD: 10/23/2022
- 06102021:69 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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