FDA recall D-1470-2016

Product

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

Reason for recall

Superpotent drug: Out of specification test result for assay during stability testing.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-24

Report date

2016-08-31

Termination date

2017-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1470-2016