buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Ph
Summary
The FDA issued a Class II for buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottl by Rising Pharma Holding, Inc.. Reason: Presence of Foreign Tablets/Capsules.
Details
Source
Drug Recall
External ID
D-0222-2024
Action Date
2024-01-17
Status
Ongoing
Category
drug
Product Description
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
Lot/Code Info: Lot #: BPA123098A, Exp. Date 06/2025
Quantity Affected: 47,976 bottles
Reason for Recall
Presence of Foreign Tablets/Capsules
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-29
Company
East Brunswick, NJ
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 20 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 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 (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-0222-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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