FDA Drug Recalls

Recalls / Class II

Class IID-0667-2022

Product

Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Affected lot / code info
Lot #: 07312020@5 BUD: 8/14/2020

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
1 bag
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-0667-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls