# FDA recall D-0612-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2024-06-28.

## Product

Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,

## Reason for recall

Failed Dissolution Specifications: results below specifications

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0612-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-06-28
- **Report date:** 2024-07-24

- **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-0612-2024

## Citation

> AI Analytics. FDA recall D-0612-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0612-2024. Source: US FDA. Licensed CC0.

---

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