SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-1145-2022 · 05/06/2022

Class II: Risk

Recall Details

Recall Number: D-1145-2022
Classification: Class II
Product Type: Drug
Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Terminated
Date Initiated: 05/06/2022
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4625 syringes

Reason for Recall

Lack of assurance of sterility

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.

Distribution Pattern

USA Nationwide

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Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

View all recalls by SUN PHARMACEUTICAL INDUSTRIES INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.