May 2017 FDA Recall Benzonatate by Strides Pharma Inc
D-0858-2017 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Strides Pharma Inc on May 9, 2017 for the product Benzonatate. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0858-2017

Reason for Recall
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Initiated
05-09-2017
Reported
05-31-2017
Quantity
127,517 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77311
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Strides Pharma 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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-22-2017
Product Description About Product Description
Full technical description of the product.
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

64380-712-06 Benzonatate
64380-712-07 Benzonatate
64380-713-06 Benzonatate
64380-713-07 Benzonatate