Why it was recalled
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
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
Lot numbers, UPCs & expiration codes
Lot #: LEV5019021A, Exp 10/2021
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0109-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 10, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- 5451 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EYWA PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0109-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86740
- Address
- 2 Research Way
- Address (line 2)
- Floor 3
- Code information
- Lot #: LEV5019021A, Exp 10/2021
- Postal code
- 08540-6628
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0109-2021
- Classification
- Class II
- Recalling firm
- EYWA PHARMA INC
- Product quantity
- 5451 bottles
- Termination date
- Oct 16, 2024
- Reason for recall
- Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Nov 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 25, 2020