Reported Nov 30, 2016 · Terminated

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma…

West-Ward Pharmaceuticals Corp.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: West-Ward Pharmaceuticals Corp. · 401 Industrial Way West · Eatontown, NJ · 07724-2209

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #: AS1466A
    • Exp. Jan 2019
Amount recalled
32,102 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 16, 2017 · Data as of Sep 19, 4:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.