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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot H45241, exp. 11/16
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1443-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 8, 2014
- FDA report date
- Jul 23, 2014
- Quantity
- 1200 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1443-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68660
- Address
- 235 East 42nd Street
- Code information
- Lot H45241, exp. 11/16
- Postal code
- 10017-5703
- Report date
- Jul 23, 2014
- Product type
- Drugs
- Recall number
- D-1443-2014
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1200 tablets
- Termination date
- Jul 6, 2015
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 8, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2014