US Drug Recall Register
Class I · High risk Terminated Initiated Jul 29, 2016 (10 years ago)

COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.

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) 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.

Recalling firm
Sage Products LLC
NDC code
53462-915-50
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0229-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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