The Recall Desk
SevereFDA (Drugs)·D-0661-2022·Announced 2022-03-23

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.

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: 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
Hazard
  • lack-of-sterility
  • contamination-risk
  • injection-safety

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:

  • NC

Related recalls

Same category