FDA Recalls NDC 43598-635 Levetiracetam
Levetiracetam Injection Injection Intravenous

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Levetiracetam with NDC 43598-635 was initiated on 10-26-2018 as a Class I recall due to labeling: label error on declared strength; the pre-printed text on the primary infusion bag and the ndc incorrectly identifies the product as levetiracetam in 0.75% sodium chloride (1000 mg/100 ml) however, the external foil pouch correctly identifies the product as levetiracetam in 0.54% sodium chloride injection (1,500/100 ml). The latest recall number for this product is D-0485-2019 and the recall is currently completed .

Recall Number D-0485-2019

Field Name Field Value
Event ID 81441 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0485-2019 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 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 Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52
Reason For Recall Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL). What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 2770 bags; 277 selling units 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 02-20-2019
Recall Initiation Date 10-26-2018 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 Dr. Reddy's Laboratories, Inc.
Code Info ABD807, exp 05/2020 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 43598-635-52; 43598-635-10; 43598-636-52; 43598-636-10; 43598-637-52; 43598-637-10; 3435986375
Status Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.
View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.