Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Ph...
FDA Recall #D-0109-2021 — Class II — November 10, 2020
Product Description
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
Reason for Recall
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Recalling Firm
EYWA PHARMA INC — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5451 bottles
Distribution
USA Nationwide
Code Information
Lot #: LEV5019021A, Exp 10/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated