Metformin Hydrochloride Tablet, Film Coated
FDA Recall NDC 65862-009
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 65862-009). A significant event, classified as Class III, was initiated on Feb 02, 2018 by Aurobindo Pharma Limited. The reported reason for this action was: "Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg"
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
Class III Terminated
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Feb 02, 2018
Feb 28, 2018
7476 bottles
Recall Profile & Regulatory Data
Event ID
79119
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US
Termination Date
Feb 18, 2021
Product Description
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
Batch or Lot Expiration Information
Lot# : MTSC17145-A, Exp. July 2021
Affected Packages Involved in this Recall
65862-008-50Product
65862-008-60Product
65862-008-90Product
65862-008-01Product
65862-008-33Product
65862-008-05Product
65862-008-99Product
65862-008-45Product
65862-009-50Product
65862-009-60Product
65862-009-90Product
65862-009-01Product
65862-009-33Product
65862-009-05Product
65862-009-99Product
65862-009-44Product
65862-010-50Product
65862-010-60Product
65862-010-90Product
65862-010-01Product
65862-010-33Product
65862-010-05Product
65862-010-99Product
65862-010-46Product
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.
