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.
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: 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.
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