# FDA recall D-0109-2018

> **Sun Pharmaceutical Industries, Inc.** · Class II · drug recall initiated 2017-04-18.

## Product

Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles,  Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512

## Reason for recall

Microbial Contamination of Non-Sterile Products

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0109-2018
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-18
- **Report date:** 2017-12-20
- **Termination date:** 2018-05-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0109-2018

## Citation

> AI Analytics. FDA recall D-0109-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0109-2018. Source: US FDA. Licensed CC0.

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