Drug Enforcement D-607-2013

Failed Dissolution Specification

Status

Terminated

Classification

Class III

Report Date

June 26, 2013

Termination Date

June 5, 2015

Product Information

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.
Product quantity
5,410 botlles
Reason for recall
Failed Dissolution Specification
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Pfizer Inc
Address
100 North Route 206

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-607-2013
Event ID
65324
Recall initiation date
May 31, 2013
Center classification date
June 19, 2013
Code info
Lot #: a) C120138, Exp 07/13; b) C120137, Exp 07/13
More code info
—