Medroxyprogesterone Acetate Injection, Suspension
FDA Recall NDC 62756-091
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Medroxyprogesterone Acetate (NDC 62756-091). A significant event, classified as Class II, was initiated on May 06, 2022 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Lack of assurance of sterility"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of assurance of sterility
May 06, 2022
Jun 22, 2022
4625 syringes
Recall Profile & Regulatory Data
Event ID
90151
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Aug 14, 2023
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.
Batch or Lot Expiration Information
Lot# : HAC1951A, Exp 06/2023
Affected Packages Involved in this Recall
62756-091-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
