Drug product
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
D-1499-2014
Product summary
- Event
- Event 67882
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89,215 blister pack
- Official record key
drug-enforcement:D-1499-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Code information: 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.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification