November 2020 FDA Recall Drug by Eywa Pharma Inc
D-0109-2021 - Presence of foreign tablet/capsule

This Class II drug recall was voluntarily initiated by Eywa Pharma Inc on November 10, 2020 for the product Drug. The FDA reported the reason for recall as presence of foreign tablet/capsule. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0109-2021

Reason for Recall
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Initiated
11-10-2020
Reported
12-02-2020
Quantity
5451 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86740
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
EYWA PHARMA 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.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2024
Product Description About Product Description
Full technical description of the product.
Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52

Batch or Lot Expiration Information

Lot# : LEV5019021A, Exp 10/2021