Benzonatate Capsule
FDA Recall NDC 68382-247
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 68382-247). A significant event, classified as Class II, was initiated on Dec 23, 2014 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules."
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 Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Dec 23, 2014
Dec 31, 2014
19,536 units
Recall Profile & Regulatory Data
Event ID
70101
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 22, 2017
Product Description
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
Batch or Lot Expiration Information
Lot# : MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Affected Packages Involved in this Recall
68382-247-01Product
68382-247-05Product
68382-091-01Product
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.
