Drug recall D-0334-2021

Class II Terminated reported Apr 21, 2021

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

Lots and codes

Lot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022

Recall details

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Quantity
13,834 bottles
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
March 31, 2021
Terminated
April 14, 2022

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