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FDAFDA · Food and drugs·Recall number D-1176-2022

Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

Published July 13, 2022 · Recall initiated: June 3, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

What to do

Voluntary: Firm initiated

Recall details

Brand
TESTOSTERONE CYPIONATE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Distributor
nationwide.
UPC
0362756017405
Lot
Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022
Risk classification
Class II
Area (FDA)
drug
Country
United States

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