Recall Enforment Report D-0085-2023

Drug Recall Enforcement Report Class II voluntary initiated by SUN PHARMACEUTICAL INDUSTRIES INC, originally initiated on 12-01-2022 for the product 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. The product was recalled due to presence of foreign substance. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 91311 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0085-2023 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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 What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 12-28-2022
Recall Initiation Date 12-01-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm SUN PHARMACEUTICAL INDUSTRIES INC
Code Info a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 62756-183-83; 62756-183-88; 62756-183-08; 62756-183-13; 62756-183-18; 62756-184-83; 62756-184-88; 62756-184-08; 62756-184-13; 62756-184-18; 62756-185-83; 62756-185-88; 62756-185-08; 62756-185-13; 62756-185-18
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
62756-183Oxcarbazepine OxcarbazepineTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
62756-184Oxcarbazepine OxcarbazepineTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
62756-185Oxcarbazepine OxcarbazepineTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug