Recall: D-0147-2017

Class III - Minor Violations

Class IIIClassification

2016-11-04Initiated

TerminatedStatus

West-Ward Pharmaceuticals CorpFirm

Product

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01

Reason

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.