Drug 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.
D-0085-2023
Product summary
- Event
- Event 91311
- Status
- Terminated
- Classification
- Class II
- Quantity
- Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles
- Official record key
drug-enforcement:D-0085-2023
Official wording
Reason: Presence of foreign substance
Code information: a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
foreign substance