SigmaPharm Laboratories LLC: Drug Recall

Recall #D-0898-2021 · 09/21/2021

Class II: Risk

Recall Details

Recall Number: D-0898-2021
Classification: Class II
Product Type: Drug
Recalling Firm: SigmaPharm Laboratories LLC
Status: Terminated
Date Initiated: 09/21/2021
Location: Bensalem, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1192 bottles

Reason for Recall

Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.

Product Description

Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14

Distribution Pattern

Nationwide

Other Recalls by SigmaPharm Laboratories LLC

Class II: Risk 08/13/2021

Failed Impurities 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.