COMFORT SHIELD Barrier Cream Cloths recalled over manufacturing violations

Recall date

July 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sage Products LLC recalls COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, fu…

Recall number

D-0230-2017

FDA classification

Class II

Brand / firm

Sage Products LLC

Sold / 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.

Why it was recalled

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.