Recall Enforment Report D-0812-2021

Drug Recall Enforcement Report Class II voluntary initiated by Aurobindo Pharma USA Inc., originally initiated on 09-09-2021 for the product Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99 The product was recalled due to presence of foreign substance: product complaints received for the presence of metal wire in one tablet.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88639 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0812-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
Reason For Recall Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 2,820 bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 09-29-2021
Recall Initiation Date 09-09-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Aurobindo Pharma USA Inc.
Code Info Lot: MJ1019025-A, Exp. date 04/2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 65862-062-01; 65862-062-99; 65862-063-60; 65862-063-01; 65862-063-99; 65862-064-60; 65862-064-01; 65862-064-99
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
65862-062Metoprolol Tartrate Metoprolol TartrateTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-063Metoprolol Tartrate Metoprolol TartrateTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-064Metoprolol Tartrate Metoprolol TartrateTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug