Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-1
Summary
The FDA issued a Class II for Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories by SigmaPharm Laboratories LLC. Reason: Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing..
Details
Source
Drug Recall
External ID
D-0766-2021
Action Date
2021-09-01
Status
Terminated
Category
drug
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
Lot/Code Info: Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
Quantity Affected: 1,993 bottles
Reason for Recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Distribution
Disttibuted Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-13
Company
Bensalem, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SigmaPharm Laboratories LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SigmaPharm Laboratories LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SigmaPharm Laboratories LLC have FDA actions?
SigmaPharm Laboratories LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0766-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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