Home / Recalls / SigmaPharm Laboratories LLC / D-0379-2021

D-0379-2021 Class III Terminated

Recalled by SigmaPharm Laboratories LLC — Bensalem, PA

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
6266 bottles

Product Description

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

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 # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022

Other recalls by SigmaPharm Laboratories LLC

  • D-0898-2021 Class II — Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottle (September 21, 2021)
  • D-0766-2021 Class II — Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories (August 13, 2021)
  • D-0380-2021 Class III — Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratorie (April 19, 2021)
  • D-1344-2014 Class II — Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-0 (April 22, 2014)