D-0229-2017 Class I Terminated
FDA drug recall D-0229-2017 was initiated by Sage Products LLC on Jul 29, 2016 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. The recall status is terminated (terminated Mar 11, 2019). Affected quantity: 576,802 cases total for product codes 7503, 7905, and 7526.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 28, 2016
- Initiation Date
- Jul 29, 2016
- Termination Date
- Mar 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 576,802 cases total for product codes 7503, 7905, and 7526
Product Description
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
Reason for Recall
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Distribution Pattern
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Code Information
Lot #: a) 53957, Exp 03/06/18; b) 54769, Exp 04/22/18; 54922, Exp 05/03/18; 55781, Exp 06/19/18; c) 53095, Exp 07/13/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0229-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026