FDAClass IIOctober 2, 2019

Fexofenadine HCl Tablets recall: Impurity Out of Spec

Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09

Why was Fexofenadine HCl Tablets recalled?

Failed Impurities/Degradation Specifications

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 #: G0219K, Exp 3/2021; C1419E, Exp 3/2021

Product
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
Recalling firm
Preferred Pharmaceuticals, Inc
Quantity
79 (90 ct.) bottles
Distribution
Product was distributed to 1 physician in Gainesville Florida.
Recall date
October 2, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls