FDA recall D-0556-2023

Product

Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA

Reason for recall

Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-04-20

Report date

2023-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burbank, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0556-2023