FDA recall D-0379-2021

Product

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

Reason for recall

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2021-04-19

Report date

2021-05-26

Termination date

2022-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bensalem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0379-2021