Drug recall D-0372-2021

Class II Terminated reported May 19, 2021

Product

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.

Reason for recall

Presence of foreign substance: identified as activated carbon.

Lots and codes

Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023.

Recall details

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Quantity
50868 bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 4, 2021
Terminated
June 27, 2023

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