FDA recall D-0768-2023

Product

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

Reason for recall

Labeling: Incorrect or Missing Package Insert

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2023-04-27

Report date

2023-05-31

Termination date

2024-02-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0768-2023