FDA-Drug2022-06-22Class II

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40.

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Lack of assurance of sterility

Sold states
USA Nationwide
Affected count
4625 syringes
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1145-2022

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