FDA-Drug2022-06-29Class II
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Sold states
Nationwide within the United States
Affected count
47,500 vials
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1154-2022Don't want to check this manually?
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