Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure
Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because it failed impurity specifications during stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
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
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 (2)
- Lot #: 011198
- Exp 01/22
Distribution
Distributed nationwide across the United States.
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