D-1573-2014 Class II Terminated
FDA drug recall D-1573-2014 was initiated by Sage Products Inc on Aug 27, 2014 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination. The recall status is terminated (terminated Feb 8, 2016). Affected quantity: 8-ct. 7,066 cases; 24-ct. 2,664 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 10, 2014
- Initiation Date
- Aug 27, 2014
- Termination Date
- Feb 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8-ct. 7,066 cases; 24-ct. 2,664 cases
Product Description
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
Reason for Recall
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Distribution Pattern
Nationwide
Code Information
Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1573-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026