Drug recall D-0085-2023
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.
Reason for recall
Presence of foreign substance
Lots and codes
a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 1, 2022
- Terminated
- September 13, 2023
Related products
- Oxcarbazepine – drug information
- NDC 62756-184 Oxcarbazepine · Oxcarbazepine 300 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 62756-183 Oxcarbazepine · Oxcarbazepine 150 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 62756-185 Oxcarbazepine · Oxcarbazepine 600 mg/1 · Sun Pharmaceutical Industries, Inc.