Finasteride Tablet, Film Coated
FDA Recall NDC 31722-525
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 Finasteride (NDC 31722-525). A significant event, classified as Class III, was initiated on Dec 29, 2016 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product."
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 III Terminated
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Dec 29, 2016
Feb 08, 2017
20,412 units
Recall Profile & Regulatory Data
Event ID
76120
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hetero Drugs Ltd. - Unit 1
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ only.
Termination Date
Jul 11, 2017
Product Description
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Batch or Lot Expiration Information
Lot# : FIN16002, Exp. 03/2018
Affected Packages Involved in this Recall
31722-525-30Product
31722-525-01Product
31722-525-10Product
31722-525-90Product
31722-525-05Product
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.
