Drug & medication recalls Moderate risk

Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries,…

Recall date
July 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0977-2018
FDA classification
Class II
Brand / firm
Sun Pharmaceutical Industries, Inc.
Sold / distributed
Nationwide within the United States

Why it was recalled

Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.

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

What was recalled

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40

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