March 2021 FDA Recall Riomet by Sun Pharmaceutical Industries Inc
D-0334-2021 - Microbial Contamination of Non-Sterile Product
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on March 31, 2021 for the product Riomet. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0334-2021
Microbial Contamination of Non-Sterile Product
03-31-2021
04-21-2021
13,834 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
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
