Asenapine Tablet
FDA Recall NDC 42794-016
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Asenapine (NDC 42794-016). A significant event, classified as Class III, was initiated on Apr 19, 2021 by Sigmapharm Laboratories, Llc. The reported reason for this action was: "Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
April 2021 Class III Recall: Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Recall Number
Class III Terminated
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Apr 19, 2021
May 26, 2021
6266 bottles
Recall Profile & Regulatory Data
Event ID
87748
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SigmaPharm Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Sep 26, 2022
Product Description
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Batch or Lot Expiration Information
Lot# Lots # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022
Affected Packages Involved in this Recall
42794-016-22Product
42794-016-08Product
42794-016-10Product
42794-017-22Product
42794-017-08Product
42794-017-10Product
April 2021 Class III Recall: Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Recall Number
Class III Terminated
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Apr 19, 2021
May 26, 2021
8786 bottles
Recall Profile & Regulatory Data
Event ID
87748
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SigmaPharm Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Sep 26, 2022
Product Description
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Batch or Lot Expiration Information
Lot# Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022
Affected Packages Involved in this Recall
42794-016-22Product
42794-016-08Product
42794-016-10Product
42794-017-22Product
42794-017-08Product
42794-017-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
