Trimix Injectable Vials Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Trimix (Alprostadil/Papaverine/Phentolamine) injectable vials distributed in North Carolina due to lack of assurance of sterility.
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: The FDA classified this as a Class II recall. The hazard—lack of sterility assurance in an injectable drug—poses a direct risk of serious harm (infection, sepsis) to patients who use affected vials, meeting the threshold for Severe classification even though no illnesses are reported in the source text.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg injectable vials in 5 mL vials because the firm cannot assure the sterility of the product.
The affected lots are: - Lot #07232020@1 (BUD: 9/6/2020) - Lot #07282020@1 (BUD: 9/11/2020) - Lot #07282020@2 (BUD: 9/11/2020)
The product was distributed in North Carolina only. Trimix is a prescription-only injectable medication.
Patients currently using this product should contact their healthcare provider or pharmacy for guidance.
The recalled product
- Product
- Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Injectable
- Affected units
- 5
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 (3)
- Lot #:07232020@1 BUD: 9/6/2020
- 07282020@1 BUD: 9/11/2020
- 07282020@2 BUD: 9/11/2020
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.
See all 12 products in this recall →Related recalls
Same manufacturer · Family Pharmacy of Statesville
See all →- SevereHydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- SevereMethylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- SevereMorphine Sulfate Infusion Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2022-03-23
- SevereKetamine 50 mg Infusion Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- HighTrimix Injectable Vials Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighTriMix Injectable Medication Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighTriMix Injection Recalled Nationwide for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighTriMix Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- SeverePharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2019-06-19
- SevereTri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- HighTriMix Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18