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Class III: unlikely to cause harmTerminated

Actavis Laboratories, FL Cartia XT Recall

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90…

Actavis Laboratories, FL, Inc. · Davie, FL

Risk level
Class III
Reported by FDA
Apr 22, 2015
Recall ID
D-0488-2015
Check your lot numberHow we source this data

Summary

Actavis Laboratories, FL recalled Cartia XT starting Mar 26, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0488-2015 on Apr 22, 2015. Reason: Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell. Status: Terminated.

Why it was recalled

Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell

Product description

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90

Lot numbers, UPCs & expiration codes

Lot # 956000M, Exp. Aug 2016; UPC 3-6203760090-6

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-0488-2015
Classification
Class III
Status
Terminated
Recall initiated
Mar 26, 2015
FDA report date
Apr 22, 2015
Quantity
2,628 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Actavis Laboratories, FL, Inc.

Original FDA data

Every field from FDA enforcement report D-0488-2015, exactly as published.

Show all FDA fields
City
Davie
State
FL
Status
Terminated
Country
United States
Event ID
70849
Address
4955 Orange Dr
Code information
Lot # 956000M, Exp. Aug 2016; UPC 3-6203760090-6
Postal code
33314-3902
Report date
Apr 22, 2015
Product type
Drugs
Recall number
D-0488-2015
Classification
Class III
Recalling firm
Actavis Laboratories, FL, Inc.
Product quantity
2,628 bottles
Termination date
Dec 30, 2016
Reason for recall
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Voluntary / mandated
Voluntary: Firm initiated
Product description
Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90
Distribution pattern
Nationwide
Recall initiation date
Mar 26, 2015
Initial firm notification
Letter
Center classification date
Apr 15, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0488-2015, published Apr 22, 2015. View the source record (openFDA) · FDA enforcement reports

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

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