Norpace Cr Capsule, Extended Release
FDA Recall NDC 0025-2732
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Norpace Cr (NDC 0025-2732). A significant event, classified as Class III, was initiated on Dec 02, 2015 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "Failed Dissolution Specification"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Dissolution Specification
Dec 02, 2015
Dec 16, 2015
a) 4005 bottles, b) 104 bottles
Recall Profile & Regulatory Data
Event ID
72716
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 26, 2017
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.
Batch or Lot Expiration Information
Lot# : C150065; C150064, Exp 6/16
Affected Packages Involved in this Recall
0025-2752-31Product
0025-2762-31Product
0025-2732-31Product
0025-2742-31Product
0025-2742-51Product
Class III Terminated
Failed Dissolution Specification
May 31, 2013
Jun 26, 2013
5,410 botlles
Recall Profile & Regulatory Data
Event ID
65324
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 05, 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.
Batch or Lot Expiration Information
Lot# : a) C120138, Exp 07/13; b) C120137, Exp 07/13
Affected Packages Involved in this Recall
0025-2752-31Product
0025-2762-31Product
0025-2732-31Product
0025-2742-31Product
0025-2742-51Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
