CLASS II Drug recall · Reported 10 Sep 2014 · FDA Enforcement Report
Comfort Shield Barrier Cream Cloths with dimethicone a) recalled
Sage Products is recalling Comfort Shield Barrier Cream Cloths with dimethicone a), distributed nationwide in the US. The recall was initiated on 27 Aug 2014 and the FDA has classified it as Class II.
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-1573-2014
- FDA event ID
- 69141
- Recalling firm
- Sage Products, Cary, IL
- Manufacturer
- Sage Products LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2014
- FDA classified
- 3 Sep 2014
- Reported
- 10 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 27 Aug 2014 | Recall initiated by company | |
| 3 Sep 2014 | Classified by FDA | +7 days |
| 10 Sep 2014 | Published in enforcement report | +7 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: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
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 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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Which lots are affected?
Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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| Drug | CLASS II | Q CARE q4 Oral Cleaning & Suctioning System Contains recalled | Sage Products | Packaging Defects | Nationwide |
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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 I | Comfort Shield (dimethicone) Barrier Cream Cloths recalledComfort Shield Barrier | Sage Products | Sterility | Nationwide |