Benzonatate Capsule
FDA Recall NDC 68084-214
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Benzonatate (NDC 68084-214). A significant event, classified as Class III, was initiated on Dec 26, 2023 by American Health Packaging. The reported reason for this action was: "Superpotent drug: Assay results were slightly above specification at the time zero point."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Superpotent drug: Assay results were slightly above specification at the time zero point.
Dec 26, 2023
Jan 31, 2024
6,344 cartons
Recall Profile & Regulatory Data
Event ID
93778
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Batch or Lot Expiration Information
Lot# 1014208, Exp Mar/31/2025
Affected Packages Involved in this Recall
68084-214-11Product
68084-214-01Product
January 2015 Class II Recall: Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Recall Number
Class II Terminated
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Jan 06, 2015
Apr 08, 2015
2284 cartons (100 individual unit doses per carton)
Recall Profile & Regulatory Data
Event ID
70320
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 23, 2015
Product Description
Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
Batch or Lot Expiration Information
Lot# AHP lot number 145513, exp 6/2016
Affected Packages Involved in this Recall
68084-214-11Product
68084-214-01Product
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.
