Fentanyl Citrate Injection Recall Due to Lack of Sterility Assurance

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, supplied as 2500 mcg/250 mL (10 mcg/mL) bags in cases of 10 bags each. This is a prescription-only injectable medication manufactured at the Nephron 503B outsourcing facility in West Columbia, South Carolina.

The recall was initiated due to lack of assurance of sterility. The affected lot numbers are FN2001A and FN2001B (expiration date 7/8/2022), FN2002A and FN2002B (expiration date 7/19/2022), and FN2003A and FN2003B (expiration date 8/24/2022).

Approximately 9,410 bags were distributed nationwide in the United States. Healthcare facilities and providers who received these affected lots should verify their inventory and take appropriate action to prevent use of the recalled product.

For injectable medications, lack of sterility assurance presents a potential risk of microbial contamination that could result in infection. Any adverse events associated with use of this product should be reported to the FDA immediately.

The recalled product

Product

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

Manufacturer

Nephron Sterile Compounding Center LLC

Category

Drug — Injectable

Hazard

• lack-of-sterility
• infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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