# FDA recall D-1120-2019

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2019-03-25.

## Product

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India.   Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05

## Reason for recall

Presence Of  Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1120-2019
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-25
- **Report date:** 2019-04-17
- **Termination date:** 2020-09-14

- **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-1120-2019

## Citation

> AI Analytics. FDA recall D-1120-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1120-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*