August 2014 FDA Recall Comfort Shield Barrier by Sage Products Inc
D-1573-2014 - Microbial Contamination of Non-Sterile Products
This Class II drug recall was voluntarily initiated by Sage Products Inc on August 27, 2014 for the product Comfort Shield Barrier. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1573-2014
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
08-27-2014
09-10-2014
8-ct. 7,066 cases; 24-ct. 2,664 cases
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sage Products Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-08-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013
Batch or Lot Expiration Information
Lot# Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
