FDAClass IIINovember 30, 2016

Amoxicillin for Oral suspension recall: Labeling Error

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman…

Why was Amoxicillin for Oral suspension recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: AS1466A, Exp. Jan 2019

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…
Recalling firm
West-Ward Pharmaceuticals Corp.
Quantity
32,102 bottles
Distribution
Nationwide
Recall date
November 30, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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