Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC… — Class II drug recall D-1573-2014
Terminated recall by Sage Products Inc, reported 2014-09-10, distributed nationwide. Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive f
| Recall number | D-1573-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sage Products Inc, Cary, IL, United States |
| Recall initiated | 2014-08-27 |
| Classified | 2014-09-03 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2016-02-08 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| NDC | 53462-0915, 53462-0915-24, 53462-0915-50, 53462-0915-51, 53462-0915-60, 53462-0915-62, 53462-0915-80, 53462-0915-81 |
| Lot numbers | 06/16, 12/15, 44385, 44669 |
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
Reason for recall
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1573-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.