D-1241-2019 Class III Terminated
FDA drug recall D-1241-2019 was initiated by Akorn Inc on April 23, 2019 and is designated Class III. 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. The recall status is terminated (terminated July 28, 2022). Affected quantity: 5,380 cartons (25 ampules per carton).
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2019
- Initiation Date
- April 23, 2019
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,380 cartons (25 ampules per carton)
Product Description
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
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 Pattern
U.S.A. Nationwide
Code Information
Lot #: 011198, Exp 01/22