FDAClass IIIJuly 23, 2014

Viracept recall: Labeling Error

VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70

Why was Viracept recalled?

Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.

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 H45241, exp. 11/16

Product
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70
Recalling firm
Pfizer Inc.
Quantity
1200 tablets
Distribution
Nationwide and Puerto Rico
Recall date
July 23, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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