AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canad...
FDA Recall #D-0165-2024 — Class II — January 26, 2022
Product Description
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling Firm
CARDINAL HEALTHCARE — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3 units
Distribution
Nationwide USA
Code Information
Batch 35447184A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated