Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ
Summary
The FDA issued a Class III for Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising P by Rising Pharma Holding, Inc.. Reason: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in.
Details
Source
Drug Recall
External ID
D-0541-2024
Action Date
2024-06-12
Status
Ongoing
Category
drug
Product Description
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
Lot/Code Info: Lot: 23132611, Exp 07/31/2026
Quantity Affected: N/A
Reason for Recall
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-16
Company
East Brunswick, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 113 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Rising Pharma Holding, Inc. has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Rising Pharma Holding, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rising Pharma Holding, Inc. have FDA actions?
Rising Pharma Holding, Inc. has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0541-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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