D-1258-2020 Class III Terminated
FDA drug recall D-1258-2020 was initiated by Akorn Inc on March 25, 2020 and is designated Class III. Reason for recall: Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing. The recall status is terminated (terminated July 28, 2022). Affected quantity: 15,170 ampules.
Recall Details
- Product Type
- Drugs
- Report Date
- April 8, 2020
- Initiation Date
- March 25, 2020
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,170 ampules
Product Description
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
Reason for Recall
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot 081887A, EXP 08/2021