Drug Enforcement D-0761-2023

Failed Dissolution Specifications; during stability testing

Status

Terminated

Classification

Class II

Report Date

May 31, 2023

Termination Date

February 27, 2024

Product Information

Product description
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Product quantity
5,344 Bottles
Reason for recall
Failed Dissolution Specifications; during stability testing
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the U.S.A

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

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

Codes & Dates

Recall number
D-0761-2023
Event ID
92289
Recall initiation date
May 9, 2023
Center classification date
May 23, 2023
Code info
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
More code info
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