FDAClass IIIApril 9, 2014

Suprax recall: Impurity Out of Spec

Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South…

Why was Suprax recalled?

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

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 #s: F300736 Exp. February 2015, F300740 Exp. February 2015, F300741 Exp. February 2015

Product
Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
5,172 bottles
Distribution
Nationwide
Recall date
April 9, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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