September 2021 FDA Recall Sodium Phenylbutyrate by Sigmapharm Laboratories Llc
D-0898-2021 - Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.

This Class II drug recall was voluntarily initiated by Sigmapharm Laboratories Llc on September 21, 2021 for the product Sodium Phenylbutyrate. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification impurity results obtained during routine testing.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0898-2021

Reason for Recall
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Initiated
09-21-2021
Reported
10-06-2021
Quantity
1192 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88736
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.
Nationwide
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, 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

42794-086-14 Sodium Phenylbutyrate