Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Product description
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
Lot numbers, UPCs & expiration codes
Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;
Where it was sold
Nationwide and Puerto Rico.
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-0378-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2013
- FDA report date
- Jan 28, 2015
- Quantity
- 3,993 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-0378-2015, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66607
- Address
- 1718 Northrock Ct
- Code information
- Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;
- Postal code
- 61103-1201
- Report date
- Jan 28, 2015
- Product type
- Drugs
- Recall number
- D-0378-2015
- Classification
- Class II
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 3,993 cartons
- Termination date
- Nov 9, 2015
- Reason for recall
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Sep 26, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 21, 2015