# FDA recall D-1701-2012

> **Glenmark Generics Inc., USA** · Class II · drug recall initiated 2012-07-06.

## Product

NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.

## Reason for recall

Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1701-2012
- **Recalling firm:** Glenmark Generics Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-06
- **Report date:** 2012-10-03
- **Termination date:** 2015-08-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1701-2012

## Citation

> AI Analytics. FDA recall D-1701-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1701-2012. Source: US FDA. Licensed CC0.

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