PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 25, 2020 Initiated: March 9, 2020 #D-1047-2020

Product Description

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

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.

Details

Units Affected
1416 bottles
Distribution
U.S.A. Nationwide
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 1416 bottles.
Why was this product recalled?
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 25, 2020. Severity: Moderate. Recall number: D-1047-2020.