Reported Sep 28, 2016 · Terminated
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by:…
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 - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only
- Manufactured by
Hikma PharmaceuticalsPO Box 182400Amman 11118 - Jordan
- Distributed by
West-Ward Pharmaceutical Corp. EatontownNJ 07724NDC 00143-9887-01
- Lot codes and dates
Lot #: AS1413AAS1414AExp. 11/18
- Amount recalled
- 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
Where it was sold
- Nationwide
Why it was recalled
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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