FDA Drug · 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,

Class III · Terminated

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

Affected lots / codes — check yours against thisLot #: AS1413A, AS1414A; Exp. 11/18

Recalling firm: West-Ward Pharmaceuticals Corp., Eatontown, NJ
Classification: Class III (unlikely to cause harm)
Status: Terminated
Quantity: 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
Distribution: Nationwide
Recall initiated: August 18, 2016
Classified: September 19, 2016
Terminated: September 1, 2017
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1515-2016%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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