Tamsulosin Hydrochloride Capsule
FDA Recall NDC 67877-450
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 Tamsulosin Hydrochloride (NDC 67877-450). A significant event, classified as Class II, was initiated on Feb 22, 2019 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed 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: High Out-of-Specification dissolution results were observed during stability testing.
Feb 22, 2019
Mar 13, 2019
3,072 bottles
Recall Profile & Regulatory Data
Event ID
82223
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Mar 18, 2020
Product Description
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.
Batch or Lot Expiration Information
Lot# : 8144652, Exp Jul 2020
Affected Packages Involved in this Recall
67877-450-30Product
67877-450-60Product
67877-450-01Product
67877-450-05Product
67877-450-10Product
67877-450-33Product
67877-450-38Product
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.
