Fentanyl Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling one lot of Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure the product's 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: This is an FDA Class II recall involving a sterility defect in an injectable opioid medication. Loss of sterility assurance in intravenous drugs poses significant risk of infection and serious patient harm, meeting the Severe category threshold.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Lot #07312020@5 with a BUD of 8/14/2020, distributed in North Carolina only.
The recall was issued because the manufacturer cannot provide assurance that the product maintains sterility. Fentanyl infusion solutions must be sterile for safe intravenous use.
Patients receiving this medication should contact their healthcare provider or pharmacy immediately. Healthcare providers should not dispense or administer product from the recalled lot. Unused product should be returned to the pharmacy for proper disposal.
The recalled product
- Product
- Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Affected units
- 1
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 #: 07312020@5 BUD: 8/14/2020
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
- SevereTrimix Injectable Vials 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
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22