D-147-2013 Class II Terminated
FDA drug recall D-147-2013 was initiated by Mylan Pharmaceuticals Inc. on Jan 30, 2013 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets. The recall status is terminated (terminated Dec 23, 2013). Affected quantity: 1,894 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 13, 2013
- Initiation Date
- Jan 30, 2013
- Termination Date
- Dec 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,894 bottles
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.
Reason for recall
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Distribution pattern
Nationwide
Code information
Lot #: 1110829, Exp 05/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-147-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026