D-0085-2023 Class II Terminated
FDA drug recall D-0085-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Dec 1, 2022 and is designated Class II. Reason for recall: Presence of foreign substance The recall status is terminated (terminated Sep 13, 2023). Affected quantity: Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 28, 2022
- Initiation Date
- Dec 1, 2022
- Termination Date
- Sep 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles
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
Distribution Pattern
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0085-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026