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
Reported: July 25, 2018 Initiated: July 3, 2018 #D-0924-2018
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.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 2508 bottles
- Distribution
- AZ
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 2508 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 25, 2018. Severity: Moderate. Recall number: D-0924-2018.
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