PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: December 16, 2015 Initiated: December 2, 2015 #D-0520-2016

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

Details

Recalling Firm
Pfizer Inc.
Units Affected
a) 4005 bottles, b) 104 bottles
Distribution
Nationwide
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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.. Recalled by Pfizer Inc.. Units affected: a) 4005 bottles, b) 104 bottles.
Why was this product recalled?
Failed Dissolution Specification
Which agency issued this recall?
This recall was issued by the FDA Drug on December 16, 2015. Severity: Low. Recall number: D-0520-2016.