FDA recall D-0520-2016

Pfizer Inc. · Class III · drug

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.

Reason for recall

Failed Dissolution Specification

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-12-02
Report date: 2015-12-16
Termination date: 2017-07-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

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