Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactu...
FDA Recall #D-0147-2017 — Class III — November 4, 2016
Product Description
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
Reason for Recall
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Recalling Firm
West-Ward Pharmaceuticals Corp. — Eatontown, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
32,102 bottles
Distribution
Nationwide
Code Information
Lot #: AS1466A, Exp. Jan 2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated