December 2022 FDA Recall Oxcarbazepine by Sun Pharmaceutical Industries Inc
D-0085-2023 - Presence of foreign substance
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on December 1, 2022 for the product Oxcarbazepine. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0085-2023
Presence of foreign substance
12-01-2022
12-28-2022
Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
09-13-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023
