Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-coun...
FDA Recall #D-0520-2016 — Class III — December 2, 2015
Product Description
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
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
a) 4005 bottles, b) 104 bottles
Distribution
Nationwide
Code Information
Lot #: C150065; C150064, Exp 6/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated