FDA recall D-0460-2022

Product

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.

Reason for recall

Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-01-05

Report date

2022-01-19

Termination date

2022-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0460-2022