Drug 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.
D-147-2013
Product summary
- Event
- Event 64186
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,894 bottles
- Official record key
drug-enforcement:D-147-2013
Official wording
Reason: Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Code information: Lot #: 1110829, Exp 05/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets