PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 30, 2016 Initiated: November 4, 2016 #D-0147-2017

Product Description

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 for Recall

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

Details

Units Affected
32,102 bottles
Distribution
Nationwide
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by West-Ward Pharmaceuticals Corp.. Units affected: 32,102 bottles.
Why was this product recalled?
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 30, 2016. Severity: Low. Recall number: D-0147-2017.