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

FDA recall notice · announced May 1, 2019 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 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.

Notes

Distribution: U.S.A. Nationwide
Lot/code information: Lot #: 011198, Exp 01/22
Quantity: 5,380 cartons (25 ampules per carton)
Status: Terminated
Products in this recall event:
- 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 (D-1241-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.