FDA Drug recall D-0924-2018
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical…
- FDA Drug
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical… by Sun Pharmaceutical Industries, citing 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 d….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0924-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-03 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | AZ |
Product
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
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.
Identifiers
| ndc | 62756-142-01 |
|---|---|
| ndc | 62756-142-02 |
| ndc | 62756-143-01 |
| code_info | Lot #: JKT0042A, Exp 1/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0924-2018%22
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