Sodium Phenylbutyrate Powder
FDA Recall NDC 42794-086
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 Sodium Phenylbutyrate (NDC 42794-086). A significant event, classified as Class II, was initiated on Sep 21, 2021 by Sigmapharm Laboratories, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing."
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
September 2021 Class II Recall: Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Sep 21, 2021
Oct 06, 2021
1192 bottles
Recall Profile & Regulatory Data
Event ID
88736
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SigmaPharm Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 26, 2022
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
Batch or Lot Expiration Information
Lot# Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
Affected Packages Involved in this Recall
42794-086-14Product
Class II Terminated
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Aug 13, 2021
Sep 01, 2021
1,993 bottles
Recall Profile & Regulatory Data
Event ID
88474
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SigmaPharm Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Disttibuted Nationwide in the USA.
Termination Date
Sep 26, 2022
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
Batch or Lot Expiration Information
Lot# Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
Affected Packages Involved in this Recall
42794-086-14Product
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.
