March 2020 FDA Recall Atorvastatin Calcium by Sun Pharmaceutical Industries, Inc.
D-1047-2020 - Presence of foreign substance

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on March 9, 2020 for the product Atorvastatin Calcium. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1047-2020

Reason for Recall
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Initiated
03-09-2020
Reported
03-25-2020
Quantity
1416 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85184
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.
Sun Pharmaceutical Industries, 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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-09-2021
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05

Batch or Lot Expiration Information

Lot# : AA33617, Exp 03/2021

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