Why it was recalled
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Product description
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
Lot numbers, UPCs & expiration codes
H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16
Where it was sold
Nationwide
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-1409-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 16, 2014
- FDA report date
- Jul 2, 2014
- Quantity
- 220,761 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Us Pharmaceutical Group
Original FDA data
Every field from FDA enforcement report D-1409-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68001
- Address
- 235 E 42nd St
- Code information
- H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16
- Postal code
- 10017-5703
- Report date
- Jul 2, 2014
- Product type
- Drugs
- Recall number
- D-1409-2014
- Classification
- Class II
- Recalling firm
- Pfizer Us Pharmaceutical Group
- Product quantity
- 220,761 bottles
- Termination date
- Sep 20, 2016
- Reason for recall
- Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 16, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2014