Recalls / Class III
Class IIID-1443-2014
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
- Brand name
- Viracept
- Generic name
- Nelfinavir Mesylate
- Active ingredient
- Nelfinavir Mesylate
- Route
- Oral
- NDCs
- 63010-010, 63010-027
- FDA application
- NDA020779
- Affected lot / code info
- Lot H45241, exp. 11/16
Why it was 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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- AGOURON
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 1200 tablets
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-07-08
- FDA classified
- 2014-07-17
- Posted by FDA
- 2014-07-23
- Terminated
- 2015-07-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1443-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.