Recalls / Class III
Class IIID-1006-2019
Product
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
- Brand name
- Lansoprazole
- Generic name
- Lansoprazole
- Active ingredient
- Lansoprazole
- Route
- Oral
- NDCs
- 0093-3008, 0093-3009
- FDA application
- ANDA208784
- Affected lot / code info
- Lot #: 25Q002, Exp. 11/2019
Why it was recalled
Subpotent Drug.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 7,081 bottles
- Distribution pattern
- Nationwide in the United States.
Timeline
- Recall initiated
- 2019-03-11
- FDA classified
- 2019-03-15
- Posted by FDA
- 2019-03-27
- Terminated
- 2019-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1006-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.