Recall Enforment Report D-1842-2019

Recall Details

Drug Recall Enforcement Report Class III voluntary initiated by Aurobindo Pharma USA Inc., originally initiated on 07-29-2019 for the product Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99 The product was recalled due to labeling; incorrect or missing lot and/or exp date; some bottles labeled with lot number 05318054b instead of 05318034b. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 83436 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1842-2019 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 Product was distributed nationwide by three major distributors who may have further distributed the product. 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 Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Reason For Recall Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 2,352/1000 count 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 09-04-2019
Recall Initiation Date 07-29-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 10-28-2021 What is the Date Terminated?
The date that FDA terminated 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 05318054B, exp 3/2021 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 65862-050-30; 65862-050-45; 65862-050-90; 65862-050-01; 65862-050-00; 65862-050-99; 65862-050-26; 65862-051-30; 65862-051-45; 65862-051-90; 65862-051-01; 65862-051-00; 65862-051-99; 65862-051-26; 65862-052-30; 65862-052-45; 65862-052-90; 65862-052-01; 65862-052-00; 65862-052-99; 65862-052-26; 65862-053-30; 65862-053-45; 65862-053-90; 65862-053-01; 65862-053-00; 65862-053-99; 65862-053-22; 65862-054-30; 65862-054-45; 65862-054-90; 65862-054-00; 65862-054-99; 65862-054-39
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
65862-050 SimvastatinTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-050Simvastatin SimvastatinTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-051 SimvastatinTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-051Simvastatin SimvastatinTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-052 SimvastatinTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-052Simvastatin SimvastatinTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-053 SimvastatinTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-053Simvastatin SimvastatinTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
65862-054 SimvastatinTablet, Film CoatedAurobindo Pharma LimitedDrug For Further Processing
65862-054Simvastatin SimvastatinTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug