# FDA recall D-1038-2017

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2017-07-11.

## Product

Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ  08540 USA.

## Reason for recall

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1038-2017
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-07-11
- **Report date:** 2017-08-09
- **Termination date:** 2019-04-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2017

## Citation

> AI Analytics. FDA recall D-1038-2017. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-1038-2017. Source: US FDA. Licensed CC0.

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