FDA recall D-1499-2014

Teva Pharmaceuticals USA · Class II · 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

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

Key facts

Status: Terminated
Initiation date: 2014-04-01
Report date: 2014-08-06
Termination date: 2014-11-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1499-2014