SigmaPharm Laboratories LLC: Drug Recall

Recall #D-0766-2021 · 08/13/2021

Class II: Risk

Recall Details

Recall Number: D-0766-2021
Classification: Class II
Product Type: Drug
Recalling Firm: SigmaPharm Laboratories LLC
Status: Terminated
Date Initiated: 08/13/2021
Location: Bensalem, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,993 bottles

Reason for Recall

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Product Description

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

Distribution Pattern

Disttibuted Nationwide in the USA.

Other Recalls by SigmaPharm Laboratories LLC

Class II: Risk 09/21/2021

Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class III: Low Risk 04/19/2021

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III: Low Risk 04/19/2021

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

View all recalls by SigmaPharm Laboratories LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.