FDA-Drug2013-06-26Class 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 and Puerto Rico
Affected count
5,410 botlles
Manufactured in
100 North Route 206, Peapack, NJ, 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-607-2013

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