Drug product
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
D-0380-2021
Product summary
- Event
- Event 87748
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8786 bottles
- Official record key
drug-enforcement:D-0380-2021
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 # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 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