# FDA recall D-003-2013

> **Caraco Pharmaceutical Laboratories Ltd.** · Class II · drug recall initiated 2012-08-21.

## Product

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton),  NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.

## Reason for recall

Crystallization: Presence of crystals of Nimodipine within the capsule solution.

## Distribution

One direct account - Caraco Pharmaceutical Labroatories, LTD  Detroit, Michigan  78 sub accounts

## Key facts

- **Recall number:** D-003-2013
- **Recalling firm:** Caraco Pharmaceutical Laboratories Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-08-21
- **Report date:** 2012-10-10
- **Termination date:** 2013-11-19

- **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-003-2013

## Citation

> AI Analytics. FDA recall D-003-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-003-2013. Source: US FDA. Licensed CC0.

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