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Class II: temporary or reversible health riskTerminated

Mylan Pharmaceuticals Paliperidone Extended-release Tablets Recall

Paliperidone Extended-release Tablets, 1

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class II
Reported by FDA
May 18, 2016
Recall ID
D-0840-2016
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Paliperidone Extended-release Tablets starting Feb 12, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0840-2016 on May 18, 2016. Reason: Failed Dissolution Specifications; three month stability time point. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications; three month stability time point.

Product description

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

Lot numbers, UPCs & expiration codes

Lot: 2005441, 01/2017, Code: 0378-3978-93

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-0840-2016
Classification
Class II
Status
Terminated
Recall initiated
Feb 12, 2016
FDA report date
May 18, 2016
Quantity
2928 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0840-2016, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
73671
Address
781 Chestnut Ridge Rd
Code information
Lot: 2005441, 01/2017, Code: 0378-3978-93
Postal code
26505-2730
Report date
May 18, 2016
Product type
Drugs
Recall number
D-0840-2016
Classification
Class II
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
2928 bottles
Termination date
Oct 26, 2016
Reason for recall
Failed Dissolution Specifications; three month stability time point.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Distribution pattern
Nationwide
Recall initiation date
Feb 12, 2016
Initial firm notification
E-Mail
Center classification date
May 6, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0840-2016, published May 18, 2016. 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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