Fentanyl Citrate Injection recall: Impurity Out of Spec
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…
Why was Fentanyl Citrate Injection recalled?
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 011198, Exp 01/22
- 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…
- Recalling firm
- Akorn Inc
- Quantity
- 5,380 cartons (25 ampules per carton)
- Distribution
- U.S.A. Nationwide
- Recall date
- May 1, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)