D-1144-2022 Class II Terminated

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
June 22, 2022
Initiation Date
May 6, 2022
Termination Date
August 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
57997 syringes

Product Description

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.

Reason for Recall

Lack of assurance of sterility

Distribution Pattern

USA Nationwide

Code Information

Lot#: HAC1289A, Exo 06/2023; JKX2679A, Exp 06/2022; JKX3762A, Exp 08/2022; HAC0164A, Exp 06/2023.