December 2014 FDA Recall Benzonatate by Zydus Pharmaceuticals Usa Inc
D-0325-2015 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on December 23, 2014 for the product Benzonatate. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0325-2015

Reason for Recall
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Initiated
12-23-2014
Reported
12-31-2014
Quantity
19,536 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70101
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.
Zydus Pharmaceuticals USA Inc
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.
09-22-2017
Product Description About Product Description
Full technical description of the product.
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

68382-247-01 Benzonatate
68382-247-05 Benzonatate
68382-091-01 Benzonatate