FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Pfizer Glucotrol XL Recall

Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Di…

Pfizer Inc. · New York, NY

Risk level
Class III
Reported by FDA
Feb 12, 2014
Recall ID
D-1058-2014
Check your lot numberHow we source this data

Summary

Pfizer recalled Glucotrol XL starting Nov 4, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1058-2014 on Feb 12, 2014. Reason: Failed Dissolution Specification; 8 hr stability timepoint. Status: Terminated.

Why it was recalled

Failed Dissolution Specification; 8 hr stability timepoint

Product description

Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66

Lot numbers, UPCs & expiration codes

Lot V120131

Where it was sold

US nationwide (including PR)

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-1058-2014
Classification
Class III
Status
Terminated
Recall initiated
Nov 4, 2013
FDA report date
Feb 12, 2014
Quantity
14,357 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Pfizer Inc.

Original FDA data

Every field from FDA enforcement report D-1058-2014, exactly as published.

Show all FDA fields
City
New York
State
NY
Status
Terminated
Country
United States
Event ID
66816
Address
235 East 42nd Street
Code information
Lot V120131
Postal code
10017-5703
Report date
Feb 12, 2014
Product type
Drugs
Recall number
D-1058-2014
Classification
Class III
Recalling firm
Pfizer Inc.
Product quantity
14,357 bottles
Termination date
Jun 24, 2015
Reason for recall
Failed Dissolution Specification; 8 hr stability timepoint
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
Distribution pattern
US nationwide (including PR)
Recall initiation date
Nov 4, 2013
Initial firm notification
Letter
Center classification date
Feb 3, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1058-2014, published Feb 12, 2014. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls