Why it was recalled
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Product description
Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10
Lot numbers, UPCs & expiration codes
Lot: 0000124916 Exp. 09/30/2022
Where it was sold
Nationwide in the US
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-0630-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 26, 2021
- FDA report date
- Jun 16, 2021
- Quantity
- 210 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McKesson Corporation dba McKesson Drug Company
Original FDA data
Every field from FDA enforcement report D-0630-2021, exactly as published.
Show all FDA fields
- City
- Memphis
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 88008
- Address
- 4853 Crumpler Rd
- Code information
- Lot: 0000124916 Exp. 09/30/2022
- Postal code
- 38141-8301
- Report date
- Jun 16, 2021
- Product type
- Drugs
- Recall number
- D-0630-2021
- Classification
- Class III
- Recalling firm
- McKesson Corporation dba McKesson Drug Company
- Product quantity
- 210 cartons
- Termination date
- Sep 29, 2022
- Reason for recall
- Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 26, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2021