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Recall Observatory FDA recall evidence

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

March 26, 2015

Class III

Product summary

Firm
Actavis Laboratories, FL, Inc.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance