D-0085-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2022
- Initiation Date
- December 1, 2022
- Termination Date
- September 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