Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

Plain-English summary

Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, NDC 17478-030-25. The recall involves 5,380 cartons distributed nationwide in the U.S.A. The specific lot affected is 011198, with an expiration date of 01/22.

The recall was initiated because the product failed to meet impurity and degradation specifications. Specifically, the product showed an out-of-specification result for total impurity at 4.0% during 12-month stability testing, exceeding the limit of not more than 3.0%.

Healthcare providers and patients should stop using the affected lot and contact Akorn Inc. for further instructions or replacement. This is an FDA Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25

Manufacturer

Akorn Inc

Category

Drug — Injection

Hazard

• impurity

Is your product affected?

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

Distribution

Related recalls