CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
Comfort Shield (dimethicone) Barrier Cream Cloths recalled
Sage Products is recalling Comfort Shield (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths, distributed nationwide in the US. The recall was initiated on 29 Jul 2016 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0229-2017
- FDA event ID
- 74819
- Recalling firm
- Sage Products, Cary, IL
- Manufacturer
- Sage Products LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Jul 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 29 Jul 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +146 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Which lots are affected?
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
Where was it sold?
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 74819This product is part of a recall event; the main page for the event is 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package recalledChlorhexidine Gluconate | Sage Products | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Comfort Shield (dimethicone) Barrier Cream Cloths recalledComfort Shield Barrier | Sage Products | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Sage Products
All 72| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Other | Nationwide |
| Device | CLASS II | stryker Sage PrimaFit External Urine Management System recalled | Sage Products | Labeling Errors | IL |
| Device | CLASS II | Toothete Oral Care Sodium Bicarbonate Mouthpaste recalled | Sage Products | Other | Nationwide |
| Drug | CLASS II | Q CARE q4 Oral Cleaning & Suctioning System Contains recalled | Sage Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Q CARE q2 Oral Cleansing & Suctioning System recalled by Sage Products | Sage Products | Packaging Defects | Nationwide |
Other Dimethicone recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Comfort Shield (dimethicone) Barrier Cream Cloths recalledComfort Shield Barrier | Sage Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Comfort Shield Barrier Cream Cloths with dimethicone a) recalledComfort Shield Barrier | Sage Products | Sterility | Nationwide |