Sage Products LLC: 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 pl

Is my product affected?

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 (

• Brand COMFORT SHIELD BARRIER

Check against the official notice below — it lists the full affected range.

What happened

Sage Products LLC is recalling Comfort Shield dimethicone barrier cream cloths containing 3% dimethicone due to contamination with Burkholderia cepacia bacteria. The affected product was distributed nationwide and internationally to countries including Canada, Mexico, the United Kingdom, Australia, and others. The recall involves approximately 576,802 cases across three product codes (7503, 7905, and 7526) with specific lot numbers and expiration dates ranging from July 2017 through June 2018.

The recall notice does not specify a remedy or recommended action for consumers who have purchased this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. Distribution: Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador. Quantity: 576,802 cases total for product codes 7503, 7905, and 7526 Lot/code info: Lot #: a) 53957, Exp 03/06/18; b) 54769, Exp 04/22/18; 54922, Exp 05/03/18; 55781, Exp 06/19/18; c) 53095, Exp 07/13/17

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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