Recall: D-1470-2016

Class II - Potentially Harmful

Class IIClassification

2016-06-24Initiated

TerminatedStatus

Teva North AmericaFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.