Drug Enforcement D-147-2013

Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.

Status

Terminated

Classification

Class II

Report Date

February 13, 2013

Termination Date

December 23, 2013

Product Information

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.
Product quantity
1,894 bottles
Reason for recall
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Mylan Pharmaceuticals Inc.
Address
781 Chestnut Ridge Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-147-2013
Event ID
64186
Recall initiation date
January 30, 2013
Center classification date
February 5, 2013
Code info
Lot #: 1110829, Exp 05/14
More code info
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