Class II
Terminated
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- April 1, 2014
- Posted
- August 6, 2014
- Recall Number
- D-1499-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 89,215 blister pack
- Firm Location
- Horsham, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Distribution
Nationwide
Lot / Code Info
35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15.
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