Drug product

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

D-0379-2021

April 19, 2021

Class III

Product summary

Firm: SigmaPharm Laboratories LLC
Event: Event 87748
Status: Terminated
Classification: Class III
Quantity: 6266 bottles
Official record key: drug-enforcement:D-0379-2021

Official wording

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

Code information: Lots # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022

Distribution pattern: Nationwide in the US

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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