Class II
Terminated
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
- Company
- Akorn, Inc.
- Recall Initiated
- January 5, 2022
- Posted
- January 19, 2022
- Recall Number
- D-0460-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31,510 ampules
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Distribution
Nationwide in the USA
Lot / Code Info
Lot # 031489A, Expiration 03/31/2022
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