FDA Drug Moderate Class II Terminated

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

Reported: August 31, 2016 Initiated: June 24, 2016 #D-1470-2016

Product Description

Reason for Recall

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

Details

Recalling Firm: Teva North America
Units Affected: 53,328 bottles
Distribution: Nationwide
Location: Horsham, PA

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Teva North America. Units affected: 53,328 bottles.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 31, 2016. Severity: Moderate. Recall number: D-1470-2016.