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.
What this means for you
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
- Hazard
- lack-of-sterility
- 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 (1)
- Lot #: 07212020@ BUD: 9/4/2020
Distribution
Distributed in 1 state:
- NC
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27