D-0924-2018 Class II Terminated
FDA drug recall D-0924-2018 was initiated by Sun Pharmaceutical Industries, Inc. on Jul 3, 2018 and is designated Class II. Reason for recall: Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one… The recall status is terminated (terminated Nov 5, 2019). Affected quantity: 2508 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 25, 2018
- Initiation Date
- Jul 3, 2018
- Termination Date
- Nov 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2508 bottles
Product Description
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, 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: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Distribution Pattern
AZ
Code Information
Lot #: JKT0042A, Exp 1/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0924-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026