Class III
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- April 23, 2019
- Posted
- May 1, 2019
- Recall Number
- D-1241-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,380 cartons (25 ampules per carton)
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot #: 011198, Exp 01/22
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