COMFORT SHIELD — Class II drug recall D-0230-2017
Terminated recall by Sage Products LLC, reported 2016-12-28, distributed nationwide. CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the conta
| Recall number | D-0230-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sage Products LLC, Cary, IL, United States |
| Recall initiated | 2016-07-29 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BH, CA, DE, DK, GB, HN, IE, MX, MY, NL, PT, SA, SG, SV |
| Quantity | 616,561 cases |
| Reason classes | cgmp |
| NDC | 53462-0915, 53462-0915-24, 53462-0915-50, 53462-0915-51, 53462-0915-60, 53462-0915-62, 53462-0915-80, 53462-0915-81 |
| Expiration dates | 2016-08-17, 2016-08-18, 2016-08-19, 2016-08-20, 2016-08-21, 2016-08-23, 2016-08-25, 2016-08-26, 2016-09-01, 2016-09-02, 2016-09-09, 2016-09-10, 2016-09-17, 2016-09-20, 2016-09-23, 2016-10-05, 2016-10-08, 2016-10-18, 2016-10-22, 2016-10-27, 2016-10-29, 2016-11-01, 2016-11-02, 2016-11-04, 2016-11-06 and 115 more |
Product
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) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 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
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
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-0230-2017. 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.