Tri-Mix Papaverine Injectable Lacks Assurance of Sterility
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable due to lack of assurance of sterility. The product was distributed in 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 of a sterile injectable drug product. Lack of sterility assurance in injectable medications poses a significant risk of serious infection or harm to patients, meeting the criteria for Severe classification even without reported illnesses.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 0.5/PGE-1 20 milligram injectable (Rx only) because the product lacks assurance of sterility.
The affected product consists of 5 vials with lot numbers 07142021:10 (expiration date 10/23/2021) and 08162021:23 (expiration date 02/08/2022). The pharmacy is located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
Distribution of this injectable product extended throughout the United States, including Washington, D.C. and Puerto Rico. Consumers who have received this product should consult their healthcare provider immediately for guidance on whether the product was used and what steps to take.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 20 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-failure
- 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: 07142021:10 BUD: 10/23/2021
- 08162021:23 BUD: 02/08/2022
Distribution
Distribution scope not specified by the agency.
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