April 2017 FDA Recall Riomet by Sun Pharmaceutical Industries, Inc.
D-0109-2018 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on April 18, 2017 for the product Riomet. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0109-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
04-18-2017
Reported
12-20-2017
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78217
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-30-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# A
Lot# 160031A, A160031B; Exp. 11/17

Affected Packages Involved in this Recall

10631-238-01 Riomet
10631-238-02 Riomet
10631-206-01 Riomet
10631-206-02 Riomet