D-0109-2021 Class II Terminated

Recalled by EYWA PHARMA INC — Princeton, NJ

FDA drug recall D-0109-2021 was initiated by EYWA PHARMA INC on Nov 10, 2020 and is designated Class II. Reason for recall: Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets. The recall status is terminated (terminated Oct 16, 2024). Affected quantity: 5451 bottles.

Recall details

Product Type
Drugs
Report Date
Dec 2, 2020
Initiation Date
Nov 10, 2020
Termination Date
Oct 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5451 bottles

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.

Distribution pattern

USA Nationwide

Code information

Lot #: LEV5019021A, Exp 10/2021

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0109-2021
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0109-2021. Report a data issue: hello@regdatalab.com.