March 2015 FDA Recall Drug by Actavis Laboratories, Fl, Inc.
D-0488-2015 - Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell

This Class III drug recall was voluntarily initiated by Actavis Laboratories, Fl, Inc. on March 26, 2015 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0488-2015

Reason for Recall
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Initiated
03-26-2015
Reported
04-22-2015
Quantity
2,628 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70849
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Actavis Laboratories, FL, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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