June 2016 FDA Recall Drug by Aidarex Pharmaceuticals Llc
D-0975-2016 - Failed Impurity/Degradation Specifications

This Class II drug recall was voluntarily initiated by Aidarex Pharmaceuticals Llc on June 1, 2016 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specifications. The product was distributed in U.S. including: CA, ND, PA, TN and the recall is currently terminated.

Recall Number: D-0975-2016

Reason for Recall
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Initiated
06-01-2016
Reported
06-15-2016
Quantity
292 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74315
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.
Aidarex Pharmaceuticals LLC
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.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. including: CA, ND, PA, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-14-2016
Product Description About Product Description
Full technical description of the product.
CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.

Batch or Lot Expiration Information

Lot# : 45335-1, Expiry: 2017/02
Lot# : 46807-1, Expiry: 2017/01
Lot# : 44359-1, Expiry: 2017/02
Lot# : 44395-1, Expiry: 2017/02
Lot# : 44693-1, Expiry: 2017/02
Lot# : 44694-1, Expiry: 2017/02
Lot# : 43707-1, Expiry: 2017/03
Lot# : 47697-1, Expiry: 2017/03
Lot# : 48605-1, Expiry: 2017/03
Lot# : 48659-1, Expiry: 2017/03
Lot# : 47772-1, Expiry: 2017/05
Lot# : 48271-1, Expiry: 2017/05.