October 2018 FDA Recall Levetiracetam by Dr. Reddy's Laboratories, Inc.
D-0485-2019 - Labeling

This Class I drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on October 26, 2018 for the product Levetiracetam. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0485-2019

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).
Initiated
10-26-2018
Reported
02-20-2019
Quantity
2770 bags; 277 selling units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81441
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-04-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# ABD807, exp 05/2020

Affected Packages Involved in this Recall

43598-635-52 Levetiracetam
43598-635-10 Levetiracetam
43598-636-52 Levetiracetam
43598-636-10 Levetiracetam
43598-637-52 Levetiracetam
43598-637-10 Levetiracetam