Librax Capsule
FDA Recall NDC 0187-4100
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 Librax (NDC 0187-4100). A significant event, classified as Class III, was initiated on Apr 18, 2015 by Bausch Health Us, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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 Impurities/Degradation Specifications
Apr 18, 2015
Jun 22, 2016
6,321 bottles
Recall Profile & Regulatory Data
Event ID
70112
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 13, 2017
Product Description
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
Batch or Lot Expiration Information
Lot# : 14L024P, Exp 06/16; and 15E029P, Exp 04/19
Affected Packages Involved in this Recall
0187-4100-10Product
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.
