Recalls / Class III
Class IIID-0520-2016
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 #: C150065; C150064, Exp 6/16
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
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- a) 4005 bottles, b) 104 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-12-02
- FDA classified
- 2015-12-10
- Posted by FDA
- 2015-12-16
- Terminated
- 2017-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0520-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.