PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: June 22, 2022 Initiated: May 6, 2022 #D-1145-2022

Product Description

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.

Reason for Recall

Lack of assurance of sterility

Details

Units Affected
4625 syringes
Distribution
USA Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 4625 syringes.
Why was this product recalled?
Lack of assurance of sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on June 22, 2022. Severity: Moderate. Recall number: D-1145-2022.