Drug & medication recalls Moderate risk

Dr. Reddy's Laboratories, Inc. recalls Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limite…

Recall date
March 6, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1001-2019
FDA classification
Class II
Brand / firm
Dr. Reddy's Laboratories, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.

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

What was recalled

Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.

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