Recalls / Class II
Class IID-0660-2022
Product
Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
- Affected lot / code info
- Lot #: 07212020@ BUD: 9/4/2020
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Family Pharmacy of Statesville
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 3478 E Broad St, N/A, Statesville, North Carolina 28625-4523
Distribution
- Quantity
- 2 vials
- Distribution pattern
- NC only
Timeline
- Recall initiated
- 2020-08-06
- FDA classified
- 2022-03-17
- Posted by FDA
- 2022-03-23
- Terminated
- 2023-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0660-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.