December 2015 FDA Recall Norpace Cr by Pfizer Inc.
D-0520-2016 - Failed Dissolution Specification
This Class III drug recall was voluntarily initiated by Pfizer Inc. on December 2, 2015 for the product Norpace Cr. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0520-2016
Failed Dissolution Specification
12-02-2015
12-16-2015
a) 4005 bottles, b) 104 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-26-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : C150065; C150064, Exp 6/16
