FDA-Drug2015-12-16Class III

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.

Pfizer Inc.
Hazard

Failed Dissolution Specification

Sold states
Nationwide
Affected count
a) 4005 bottles, b) 104 bottles
Manufactured in
235 East 42nd Street, N/A, New York, NY, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0520-2016

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