Why it was recalled
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Product description
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.
Lot numbers, UPCs & expiration codes
Lot #: 1110829, Exp 05/14
Where it was sold
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-147-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 30, 2013
- FDA report date
- Feb 13, 2013
- Quantity
- 1,894 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-147-2013, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 64186
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: 1110829, Exp 05/14
- Postal code
- 26505-2730
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-147-2013
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 1,894 bottles
- Termination date
- Dec 23, 2013
- Reason for recall
- Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 30, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2013