Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
Reported: December 7, 2016 Initiated: November 2, 2016 #D-0163-2017
Product Description
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
Reason for Recall
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Details
- Recalling Firm
- Ascend Laboratories LLC
- Units Affected
- 1739 bottles
- Distribution
- AL, FL, GA, SC & TN
- Location
- Montvale, NJ
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10. Recalled by Ascend Laboratories LLC. Units affected: 1739 bottles.
Why was this product recalled? ▼
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 7, 2016. Severity: Moderate. Recall number: D-0163-2017.
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