FDAFDA · Food and drugs·Recall number D-1515-2016
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,
Published September 28, 2016 · Recall initiated: August 18, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- West-Ward Pharmaceuticals Corp.
- Distributor
- Nationwide
- Lot
- Lot #: AS1413A, AS1414A; Exp. 11/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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