FDA-Drug2016-09-28Class III

Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

West-Ward Pharmaceuticals Corp.
Hazard

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

Sold states
Nationwide
Affected count
32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
Manufactured in
401 Industrial Way West, Eatontown, NJ, United States
Products
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1515-2016

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