Riomet Solution
FDA Recall NDC 10631-238
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Riomet (NDC 10631-238). A significant event, classified as Class II, was initiated on Mar 31, 2021 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Microbial Contamination of Non-Sterile Product"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2021 Class II Recall: Microbial Contamination of Non-Sterile Product
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Product
Mar 31, 2021
Apr 21, 2021
13,834 bottles
Recall Profile & Regulatory Data
Event ID
87650
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Apr 14, 2022
Product Description
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.
Batch or Lot Expiration Information
Lot# : J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022
Affected Packages Involved in this Recall
10631-238-01Product
10631-238-02Product
10631-206-01Product
10631-206-02Product
Class III Terminated
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Apr 26, 2018
May 23, 2018
19,758 473 mL bottles
Recall Profile & Regulatory Data
Event ID
79979
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide in the USA
Termination Date
Feb 28, 2019
Product Description
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Batch or Lot Expiration Information
Lot# Lot Numbers: E170210A, EXP 06/09/2019; F170214A, 07/05/2019; F170223A, EXP 07/06/2019; F170224A EXP 07/10/2019; F170231A , EXP 07/12/2019; F170232A EXP 07/13/2019.
Affected Packages Involved in this Recall
10631-238-01Product
10631-238-02Product
10631-206-01Product
10631-206-02Product
April 2017 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products
Apr 18, 2017
Dec 20, 2017
N/A
Recall Profile & Regulatory Data
Event ID
78217
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 30, 2018
Product Description
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
10631-238-01Product
10631-238-02Product
10631-206-01Product
10631-206-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
