# FDA recall D-1081-2014

> **Caraco Pharmaceutical Laboratories Ltd.** · Class II · drug recall initiated 2014-01-29.

## Product

Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only.  Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202.  Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.  NDC 62756-184-88,    Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient.   Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage:  See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted....  Distributed by Caraco Pharmaceuticals Detroit, MI....

## Reason for recall

Failed Tablet Specifications: Broken Tablets Present.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1081-2014
- **Recalling firm:** Caraco Pharmaceutical Laboratories Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-29
- **Report date:** 2014-02-19
- **Termination date:** 2014-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cranbury, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1081-2014

## Citation

> AI Analytics. FDA recall D-1081-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1081-2014. Source: US FDA. Licensed CC0.

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