Trimix Injectable Vials Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Trimix injectable vials (Alprostadil/Papaverine/Phentolamine 20 mcg/30 mg/0.5 mg) due to lack of assurance of sterility. The recall affects 2 vials distributed in North Carolina.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterility assurance deficiency in an injectable drug product. Although no illnesses or injuries are reported in the source text, lack of sterility in injectable preparations presents a high risk of serious harm (infection, sepsis) if the product has been administered. Class II recalls typically warrant a score of 4 or higher when serious illness is reported; in the absence of reported illness but with a theoretical high-risk hazard, a score of 3 (High) applies per the rubric.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, due to lack of assurance of sterility. The recalled product consists of 2 vials with Lot #07212020 and a beyond-use date of 9/4/2020.
This recall was issued by the U.S. Food and Drug Administration (FDA), classified as a Class II recall. The product was distributed in North Carolina only.
Patients who have received this product should consult their healthcare provider regarding potential risks. Pharmacists and healthcare facilities should stop use and distribution of this product immediately and contact Family Pharmacy of Statesville for recall instructions.
The recalled product
- Product
- Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Affected units
- 2
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 #: 07212020@ BUD: 9/4/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 12 recalled by Family Pharmacy of Statesville 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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