August 2021 FDA Recall Sodium Phenylbutyrate by Sigmapharm Laboratories Llc
D-0766-2021 - Failed Impurities Specifications

This Class II drug recall was voluntarily initiated by Sigmapharm Laboratories Llc on August 13, 2021 for the product Sodium Phenylbutyrate. The FDA reported the reason for recall as failed impurities specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0766-2021

Reason for Recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Initiated
08-13-2021
Reported
09-01-2021
Quantity
1,993 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88474
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Disttibuted Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-26-2022
Product Description About Product Description
Full technical description of the product.
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

42794-086-14 Sodium Phenylbutyrate