# FDA recall D-0102-2018

> **International Laboratories, Inc.** · Class I · drug recall initiated 2017-08-07.

## Product

Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16

## Reason for recall

Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.

## Distribution

U.S.A. nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0102-2018
- **Recalling firm:** International Laboratories, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-07
- **Report date:** 2017-12-13
- **Termination date:** 2019-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** St Petersburg, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2018

## Citation

> AI Analytics. FDA recall D-0102-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0102-2018. Source: US FDA. Licensed CC0.

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