Recalls / Class II
Class IID-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.
- Brand name
- Oxcarbazepine
- Generic name
- Oxcarbazepine
- Active ingredient
- Oxcarbazepine
- Route
- Oral
- NDCs
- 62756-183, 62756-184, 62756-185
- FDA application
- ANDA077794
- Affected lot / code info
- a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023
Why it was recalled
Presence of foreign substance
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-12-01
- FDA classified
- 2022-12-19
- Posted by FDA
- 2022-12-28
- Terminated
- 2023-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0085-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.