Drug Enforcement D-0137-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class III

Report Date

December 13, 2023

Termination Date

June 27, 2024

Product Information

Product description
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
Product quantity
2016 Bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0137-2024
Event ID
93472
Recall initiation date
November 22, 2023
Center classification date
December 1, 2023
Code info
Lot HAD0630A, exp 1/2024
More code info
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