Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 67877-413
Latest: Class II · Status: Terminated · Initiated Nov 02, 2016 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 67877-413). A significant event, classified as Class II, was initiated on Nov 02, 2016 by Ascend Laboratories, Llc. The reported reason for this action was: "Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2016 Class II Recall: Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Recall Number
Class II Terminated
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Nov 02, 2016
Dec 07, 2016
1739 bottles
Recall Profile & Regulatory Data
Event ID
75698
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AL, FL, GA, SC & TN
Termination Date
Jun 07, 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
Batch or Lot Expiration Information
Lot# Lot 6121056, exp 5/2019
Affected Packages Involved in this Recall
67877-217-01Metformin Hydrochloride
67877-217-05Metformin Hydrochloride
67877-217-10Metformin Hydrochloride
67877-217-33Metformin Hydrochloride
67877-217-38Metformin Hydrochloride
67877-218-01Metformin Hydrochloride
67877-218-05Metformin Hydrochloride
67877-218-10Metformin Hydrochloride
67877-218-33Metformin Hydrochloride
67877-218-38Metformin Hydrochloride
67877-221-01Metformin Hydrochloride
67877-221-05Metformin Hydrochloride
67877-221-10Metformin Hydrochloride
67877-221-33Metformin Hydrochloride
67877-221-38Metformin Hydrochloride
67877-413-01Metformin Hydrochloride
67877-413-05Metformin Hydrochloride
67877-413-10Metformin Hydrochloride
67877-413-33Metformin Hydrochloride
67877-413-90Metformin Hydrochloride
67877-414-01Metformin Hydrochloride
67877-414-05Metformin Hydrochloride
67877-414-10Metformin Hydrochloride
67877-414-33Metformin Hydrochloride
67877-414-90Metformin Hydrochloride
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
