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Class II: temporary or reversible health riskTerminated

Mylan Pharmaceuticals glipiZIDE Extended-Release Tablets Recall

glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceut…

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class II
Reported by FDA
Mar 8, 2017
Recall ID
D-0491-2017
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled glipiZIDE Extended-Release Tablets starting Jan 19, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0491-2017 on Mar 8, 2017. Reason: Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets

Product description

glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10

Lot numbers, UPCs & expiration codes

Batch # 3074621, June 2018

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-0491-2017
Classification
Class II
Status
Terminated
Recall initiated
Jan 19, 2017
FDA report date
Mar 8, 2017
Quantity
1338 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0491-2017, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
76291
Address
781 Chestnut Ridge Rd
Code information
Batch # 3074621, June 2018
Postal code
26505-2730
Report date
Mar 8, 2017
Product type
Drugs
Recall number
D-0491-2017
Classification
Class II
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
1338 bottles
Termination date
Jul 20, 2017
Reason for recall
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Voluntary / mandated
Voluntary: Firm initiated
Product description
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
Distribution pattern
Nationwide
Recall initiation date
Jan 19, 2017
Initial firm notification
E-Mail
Center classification date
Feb 24, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0491-2017, published Mar 8, 2017. 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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