Why it was recalled
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Product description
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Lot numbers, UPCs & expiration codes
Lot ZLMM12063, Exp March 2014
Where it was sold
The product was distributed to KY.
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-1702-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 960 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1702-2012, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 62885
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot ZLMM12063, Exp March 2014
- Postal code
- 26505-2730
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1702-2012
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 960 bottles
- Termination date
- May 21, 2013
- Reason for recall
- Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
- Distribution pattern
- The product was distributed to KY.
- Recall initiation date
- Jul 27, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2012