Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Reported: July 27, 2022 Initiated: June 30, 2022 #D-1252-2022
Product Description
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 9410 bags
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 9410 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 27, 2022. Severity: Moderate. Recall number: D-1252-2022.
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