D-0372-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 19, 2021
- Initiation Date
- May 4, 2021
- Termination Date
- June 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50868 bottles
Product Description
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.
Distribution Pattern
USA Nationwide
Code Information
Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023.