# FDA recall D-397-2014

> **Watson Laboratories Inc** · Class II · drug recall initiated 2013-12-23.

## Product

Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA.  Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.

## Reason for recall

Presence of Foreign Substance; metal particulates were visually observed in the tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-397-2014
- **Recalling firm:** Watson Laboratories Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-12-23
- **Report date:** 2014-01-15
- **Termination date:** 2014-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Corona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-397-2014

## Citation

> AI Analytics. FDA recall D-397-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-397-2014. Source: US FDA. Licensed CC0.

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