D-0109-2021 Class II Terminated
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