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Recall Observatory FDA recall evidence

Drug 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

D-1443-2014

July 08, 2014

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 68660
Status
Terminated
Classification
Class III
Quantity
1200 tablets
Official record key
drug-enforcement:D-1443-2014

Official wording

Reason: 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.

Code information: Lot H45241, exp. 11/16

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or missing