January 2014 FDA Recall Atorvastatin Calcium by Ranbaxy Inc.
D-1086-2014 - Presence of Foreign Tablets

This Class II drug recall was voluntarily initiated by Ranbaxy Inc. on January 16, 2014 for the product Atorvastatin Calcium. The FDA reported the reason for recall as presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1086-2014

Reason for Recall
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Initiated
01-16-2014
Reported
03-05-2014
Quantity
64,626 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67485
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ranbaxy 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.
01-14-2015
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90

Batch or Lot Expiration Information

Lot# 2407255, 2407256 Exp. 05/14

Affected Packages Involved in this Recall

63304-827-90 Atorvastatin Calcium
63304-827-05 Atorvastatin Calcium
63304-828-90 Atorvastatin Calcium
63304-828-05 Atorvastatin Calcium
63304-829-90 Atorvastatin Calcium
63304-829-05 Atorvastatin Calcium
63304-830-90 Atorvastatin Calcium
63304-830-05 Atorvastatin Calcium