TRI-MIX Injectable Papaverine/Phentolamine/PGE-1 Lacks Sterility Assurance
Vita Pharmacy (Talon Compounding Pharmacy) is recalling one lot of TRI-MIX injectable medication because the manufacturer cannot assure the product's 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 sterile injectable product. Lack of sterility assurance in injectable medications presents a serious risk of infection and other adverse health effects if the product is used. Although no specific illnesses or hospitalizations are reported in the source text, the inherent hazard of a non-sterile injectable product and the Class II classification support a Severe rating.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 INJ (an injectable, prescription-only medication) because the manufacturer lacks assurance of sterility for the product.
The recalled product is a compounded injectable formulation distributed to healthcare providers in the United States, including Washington D.C. and Puerto Rico. The affected lot is 08042021:05, with an expiration date of 11/30/2021.
Lack of sterility assurance in injectable medications poses a risk of serious infection if contaminated product is administered. Consumers and healthcare providers who have this lot should contact the pharmacy or their healthcare provider immediately and should not use the recalled product.
The recalled product
- Product
- TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 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: 08042021:05 BUD: 11/30/2021
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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