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
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
97,450 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-1153-2022Don't want to check this manually?
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