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Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count b...

FDA Recall #D-0085-2023 — Class II — December 1, 2022

Recall #D-0085-2023 Date: December 1, 2022 Classification: Class II Status: Terminated

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.

Reason for Recall

Presence of foreign substance

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles

Distribution

Nationwide within the United States

Code Information

a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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