Progesterone Capsule
FDA Recall NDC 43598-349
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 Progesterone (NDC 43598-349). A significant event, classified as Class II, was initiated on Feb 26, 2021 by Dr. Reddy�s Laboratories, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing."
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
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Feb 26, 2021
Mar 10, 2021
16,449 bottles
Recall Profile & Regulatory Data
Event ID
87411
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Feb 17, 2022
Product Description
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.
Batch or Lot Expiration Information
Batch# 1399851P1, Exp 02/2021
Affected Packages Involved in this Recall
43598-349-01Product
43598-350-01Product
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.
