FDA recall D-1515-2016

Product

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,

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-18

Report date

2016-09-28

Termination date

2017-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

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