Drug 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
D-0488-2015
Product summary
- Event
- Event 70849
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,628 bottles
- Official record key
drug-enforcement:D-0488-2015
Official wording
Reason: Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Code information: Lot # 956000M, Exp. Aug 2016; UPC 3-6203760090-6
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance