Multi-event April 2021 FDA Recall Asenapine by Sigmapharm Laboratories Llc
This Multi-event Class III drug recall was voluntarily initiated by Sigmapharm Laboratories Llc on April 19, 2021 for the product Asenapine. The FDA reported the reason for recall as incorrect product formulation; product was manufactured with the incorrect art cherry flavor flavoring agent instead of art black cherry flavor flavoring agent. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0379-2021
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
04-19-2021
05-26-2021
6266 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SigmaPharm Laboratories LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
09-26-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0380-2021
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
04-19-2021
05-26-2021
8786 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SigmaPharm Laboratories LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
09-26-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
