SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmac
Recalled June 29, 2022 · FDA recall D-1154-2022 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion · FDA Class II
Units
47,500 vials
Sold at
Nationwide within the United States
Description
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Product
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.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →