# FDA recall D-0334-2021

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2021-03-31.

## Product

Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.

## Reason for recall

Microbial Contamination of Non-Sterile Product

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0334-2021
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-31
- **Report date:** 2021-04-21
- **Termination date:** 2022-04-14

- **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-0334-2021

## Citation

> AI Analytics. FDA recall D-0334-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0334-2021. Source: US FDA. Licensed CC0.

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