Drug Enforcement D-0044-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class III

Report Date

October 25, 2023

Termination Date

February 2, 2024

Product Information

Product description
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86
Product quantity
144 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

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-0044-2024
Event ID
93166
Recall initiation date
October 4, 2023
Center classification date
October 16, 2023
Code info
Lot #: HAD0360A, Exp. 12/2023
More code info
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