May 2013 FDA Recall Norpace Cr by Pfizer Inc
D-607-2013 - Failed Dissolution Specification

This Class III drug recall was voluntarily initiated by Pfizer Inc on May 31, 2013 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-607-2013

Reason for Recall
Failed Dissolution Specification
Initiated
05-31-2013
Reported
06-26-2013
Quantity
5,410 botlles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65324
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2015
Product Description About Product Description
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# : a) C120138, Exp 07/13; b) C120137, Exp 07/13

Affected Packages Involved in this Recall

0025-2752-31 Norpace
0025-2762-31 Norpace
0025-2732-31 Norpace Cr
0025-2742-31 Norpace Cr
0025-2742-51 Norpace Cr