D-0380-2021 Class III Terminated
FDA drug recall D-0380-2021 was initiated by SigmaPharm Laboratories LLC on April 19, 2021 and is designated Class III. 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 The recall status is terminated (terminated September 26, 2022). Affected quantity: 8786 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- April 19, 2021
- Termination Date
- September 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8786 bottles
Product Description
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
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 Pattern
Nationwide in the US
Code Information
Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022