Drug Enforcement D-0222-2024

Presence of Foreign Tablets/Capsules

Status

Ongoing

Classification

Class II

Report Date

January 17, 2024

Termination Date

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Product Information

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
Product quantity
47,976 bottles
Reason for recall
Presence of Foreign Tablets/Capsules
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Rising Pharma Holding, Inc.
Address
2 Tower Center Blvd Ste 1401

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0222-2024
Event ID
93706
Recall initiation date
December 29, 2023
Center classification date
January 11, 2024
Code info
Lot #: BPA123098A, Exp. Date 06/2025
More code info
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