# FDA recall D-1427-2012

> **Stat Rx USA** · Class III · drug recall initiated 2012-07-23.

## Product

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.

## Reason for recall

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1427-2012
- **Recalling firm:** Stat Rx USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-23
- **Report date:** 2012-08-01
- **Termination date:** 2013-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1427-2012

## Citation

> AI Analytics. FDA recall D-1427-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1427-2012. Source: US FDA. Licensed CC0.

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