January 2015 FDA Recall Benzonatate by American Health Packaging
D-0430-2015 - Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules

This Class II drug recall was voluntarily initiated by American Health Packaging on January 6, 2015 for the product Benzonatate. The FDA reported the reason for recall as failed tablet/capsule specifications; recall initiated by manufacturer due to reports of wet capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0430-2015

Reason for Recall
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Initiated
01-06-2015
Reported
04-08-2015
Quantity
2284 cartons (100 individual unit doses per carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70320
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2015
Product Description About Product Description
Full technical description of the product.
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

68084-214-11 Benzonatate
68084-214-01 Benzonatate