Recall: D-1145-2022

Class II - Potentially Harmful

Class IIClassification

2022-05-06Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

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

Lack of assurance of sterility

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.