FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Mylan Pharmaceuticals Diltiazem HCl Extended Release Capsules Recall

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan…

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class III
Reported by FDA
Sep 3, 2014
Recall ID
D-1557-2014
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Diltiazem HCl Extended Release Capsules starting Jun 19, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1557-2014 on Sep 3, 2014. Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Product description

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

Lot numbers, UPCs & expiration codes

Lot 3040063 Exp. 07/14

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-1557-2014
Classification
Class III
Status
Terminated
Recall initiated
Jun 19, 2014
FDA report date
Sep 3, 2014
Quantity
2,658 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-1557-2014, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
68645
Address
781 Chestnut Ridge Rd
Code information
Lot 3040063 Exp. 07/14
Postal code
26505-2730
Report date
Sep 3, 2014
Product type
Drugs
Recall number
D-1557-2014
Classification
Class III
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
2,658 Bottles
Termination date
Jul 23, 2015
Reason for recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Distribution pattern
Nationwide
Recall initiation date
Jun 19, 2014
Initial firm notification
Telephone
Center classification date
Aug 22, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1557-2014, published Sep 3, 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