Drug & medication recalls Moderate risk

Atorvastatin Calcium Tablets recalled over foreign material

Recall date
March 9, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Sun Pharmaceutical Industries, Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limi…
Recall number
D-1047-2020
FDA classification
Class II
Brand / firm
Sun Pharmaceutical Industries, Inc.
Sold / distributed
U.S.A. Nationwide

Why it was recalled

Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

Get recall alerts

Free email alert whenever Sun Pharmaceutical Industries, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Sun Pharmaceutical Industries, Inc.