# FDA recall D-0092-2018

> **Lupin Limited** · Class II · drug recall initiated 2017-11-17.

## Product

Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09

## Reason for recall

Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.

## Distribution

Product was distributed throughout the United States, including Puerto Rico.

## Key facts

- **Recall number:** D-0092-2018
- **Recalling firm:** Lupin Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-17
- **Report date:** 2017-11-29
- **Termination date:** 2019-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vasco Da Gama, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0092-2018

## Citation

> AI Analytics. FDA recall D-0092-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0092-2018. Source: US FDA. Licensed CC0.

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