US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 1, 2014 (12 years ago)

triple therapy

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

What was recalled

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

Recalling firm
Teva Pharmaceuticals USA
NDC code
0093-8055-78
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1499-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Lansoprazole recalls

See all
Class II · Moderate risk Terminated

Lansoprazole Delayed-Release Capsules USP

Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

NATCO Pharma Limited NDC 16571-742-41 D-0318-2024