Recalls / Class III
Class IIID-607-2013
Product
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.
- Brand name
- Norpace Cr
- Generic name
- Disopyramide Phosphate
- Active ingredient
- Disopyramide Phosphate
- Route
- Oral
- NDCs
- 0025-2732, 0025-2752, 0025-2762, 0025-2742
- FDA application
- NDA018655
- Affected lot / code info
- Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13
Why it was recalled
Failed Dissolution Specification
Recalling firm
- Firm
- Pfizer Inc
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 North Route 206, Peapack, New Jersey 07977
Distribution
- Quantity
- 5,410 botlles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-05-31
- FDA classified
- 2013-06-19
- Posted by FDA
- 2013-06-26
- Terminated
- 2015-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-607-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.