FDA-Drug2022-06-22Class II

medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, 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 16714-090-40 packaged in 25 count carton.

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Lack of assurance of sterility

Sold states
USA Nationwide
Affected count
26892 vials
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, 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 16714-090-40 packaged in 25 count carton.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1147-2022

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