Why it was recalled
Subpotent Drug.
Product description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
Lot numbers, UPCs & expiration codes
Lot #: 25Q002, Exp. 11/2019
Where it was sold
Nationwide in the United States.
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-1006-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 11, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 7,081 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1006-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 82367
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 25Q002, Exp. 11/2019
- Postal code
- 19454-1505
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1006-2019
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 7,081 bottles
- Termination date
- Nov 15, 2019
- Reason for recall
- Subpotent Drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
- Distribution pattern
- Nationwide in the United States.
- Recall initiation date
- Mar 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 15, 2019