Recalls / Class II
Class IID-147-2013
Product
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.
- Brand name
- Lansoprazole
- Generic name
- Lansoprazole
- Active ingredient
- Lansoprazole
- Route
- Oral
- NDCs
- 0378-8015, 0378-8030
- FDA application
- ANDA090763
- Affected lot / code info
- Lot #: 1110829, Exp 05/14
Why it was recalled
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 1,894 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-30
- FDA classified
- 2013-02-05
- Posted by FDA
- 2013-02-13
- Terminated
- 2013-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-147-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.