# FDA recall D-0233-2018

> **International Laboratories, Inc.** · Class II · drug recall initiated 2018-01-12.

## Product

Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.

## Reason for recall

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0233-2018
- **Recalling firm:** International Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-01-31
- **Termination date:** 2019-05-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2018

## Citation

> AI Analytics. FDA recall D-0233-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0233-2018. Source: US FDA. Licensed CC0.

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