Benzonatate Capsule
FDA Recall NDC 64380-712
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 Benzonatate (NDC 64380-712). A significant event, classified as Class III, was initiated on May 09, 2017 by Strides Pharma Science Limited. The reported reason for this action was: "Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content."
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 Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
May 09, 2017
May 31, 2017
127,517 bottles
Recall Profile & Regulatory Data
Event ID
77311
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Strides Pharma INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Dec 22, 2017
Product Description
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
Batch or Lot Expiration Information
Lot# : 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017; 7225649A, 7225650A , 7225651A , 7225652A, 7225653A, 7225654A, Exp 9/2017
Affected Packages Involved in this Recall
64380-712-06Product
64380-712-07Product
64380-713-06Product
64380-713-07Product
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.
