Drug product
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
D-0379-2021
Product summary
- 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
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent