Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure
Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because retained sample testing showed total impurities exceeded the allowed limit.
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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 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), 10 Ampules per carton. The recall involves 15,170 ampules from Lot 081887A with an expiration date of 08/2021. The product was distributed nationwide in the USA.
The recall was initiated because retained sample testing revealed an out-of-specification result for total impurity at 4.1%, which exceeds the established limit of not more than 3.0%.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare providers and patients should stop using the affected lot and contact Akorn Inc. for further instructions or replacement.
The recalled product
- Product
- Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
- Manufacturer
- Akorn Inc
- Category
- Drug — Injection
- Hazard
- Affected units
- 15,170
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 081887A
- EXP 08/2021
Distribution
Distributed nationwide across the United States.
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