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
Reported: April 8, 2020 Initiated: March 25, 2020 #D-1258-2020
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.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 15,170 ampules
- Distribution
- Distributed Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn Inc. Units affected: 15,170 ampules.
Why was this product recalled? ▼
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 8, 2020. Severity: Low. Recall number: D-1258-2020.
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