Why it was recalled
Failed Dissolution Specification
Product description
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.
Lot numbers, UPCs & expiration codes
Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13
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-607-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 31, 2013
- FDA report date
- Jun 26, 2013
- Quantity
- 5,410 botlles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc
Original FDA data
Every field from FDA enforcement report D-607-2013, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65324
- Address
- 100 North Route 206
- Code information
- Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13
- Postal code
- 07977
- Report date
- Jun 26, 2013
- Product type
- Drugs
- Recall number
- D-607-2013
- Classification
- Class III
- Recalling firm
- Pfizer Inc
- Product quantity
- 5,410 botlles
- Termination date
- Jun 5, 2015
- Reason for recall
- Failed Dissolution Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 31, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 19, 2013