Recalls / Class III
Class IIID-0488-2015
Product
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
- Affected lot / code info
- Lot # 956000M, Exp. Aug 2016; UPC 3-6203760090-6
Why it was recalled
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Recalling firm
- Firm
- Actavis Laboratories, FL, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4955 Orange Dr, N/A, Davie, Florida 33314-3902
Distribution
- Quantity
- 2,628 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-26
- FDA classified
- 2015-04-15
- Posted by FDA
- 2015-04-22
- Terminated
- 2016-12-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0488-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.