FDAClass IIMarch 29, 2017

Famciclovir tablets recall: Impurity Out of Spec

Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13

Why was Famciclovir tablets recalled?

Failed impurities/ degradation specifications: Product was above specification for unknown impurities.

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 #15152, Exp. 02/2018

Product
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Recalling firm
AVKARE Inc.
Quantity
116 cartons
Distribution
Nationwide
Recall date
March 29, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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