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Class III: unlikely to cause harmTerminated

Pfizer Norpace CR Recall

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a…

Pfizer Inc. · New York, NY

Risk level
Class III
Reported by FDA
Dec 16, 2015
Recall ID
D-0520-2016
Check your lot numberHow we source this data

Summary

Pfizer recalled Norpace CR starting Dec 2, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0520-2016 on Dec 16, 2015. Reason: Failed Dissolution Specification. Status: Terminated.

Why it was recalled

Failed Dissolution Specification

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.

Lot numbers, UPCs & expiration codes

Lot #: C150065; C150064, Exp 6/16

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0520-2016
Classification
Class III
Status
Terminated
Recall initiated
Dec 2, 2015
FDA report date
Dec 16, 2015
Quantity
a) 4005 bottles, b) 104 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Pfizer Inc.

Original FDA data

Every field from FDA enforcement report D-0520-2016, exactly as published.

Show all FDA fields
City
New York
State
NY
Status
Terminated
Country
United States
Event ID
72716
Address
235 East 42nd Street
Code information
Lot #: C150065; C150064, Exp 6/16
Postal code
10017-5703
Report date
Dec 16, 2015
Product type
Drugs
Recall number
D-0520-2016
Classification
Class III
Recalling firm
Pfizer Inc.
Product quantity
a) 4005 bottles, b) 104 bottles
Termination date
Jul 26, 2017
Reason for recall
Failed Dissolution Specification
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide
Recall initiation date
Dec 2, 2015
Initial firm notification
Letter
Center classification date
Dec 10, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0520-2016, published Dec 16, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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