Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton
Summary
The FDA issued a Class II for Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottle by SigmaPharm Laboratories LLC. Reason: Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing..
Details
Source
Drug Recall
External ID
D-0898-2021
Action Date
2021-10-06
Status
Terminated
Category
drug
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
Lot/Code Info: Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
Quantity Affected: 1192 bottles
Reason for Recall
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-21
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 107 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-0898-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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