PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 2, 2020 Initiated: November 10, 2020 #D-0109-2021

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.

Details

Recalling Firm
EYWA PHARMA INC
Units Affected
5451 bottles
Distribution
USA Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by EYWA PHARMA INC. Units affected: 5451 bottles.
Why was this product recalled?
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 2, 2020. Severity: Moderate. Recall number: D-0109-2021.