Drug Enforcement D-0085-2023

Presence of foreign substance

Status

Terminated

Classification

Class II

Report Date

December 28, 2022

Termination Date

September 13, 2023

Product Information

Product description
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), 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.
Product quantity
Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles
Reason for recall
Presence of foreign substance
Recall initiation reason
—
Initial firm notification
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Distribution pattern
Nationwide within the United States

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-0085-2023
Event ID
91311
Recall initiation date
December 1, 2022
Center classification date
December 19, 2022
Code info
a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023
More code info
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