Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
Cross Contamination with Other Products
Comfort Shield (Dimethicone)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
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.
Affected NDCs
53462-0915-50
53462-0915-51
53462-0915-60
53462-0915-62
53462-0915-80
53462-0915-81
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Comfort Shield Barrier dimethicone NDC 53462-0915 |
30 mg/g | Cloth Topical |
Sage Products LLC | OTC |
- Recalling firm
- Sage Products LLC
- NDC code
- 53462-915-50
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0230-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Sage Products LLC
All 2016 recalls
Class II · Moderate risk
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Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2%…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
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Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Other cgmp deviation recalls from 2016
All cgmp deviation recalls
Class II · Moderate risk
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Class II · Moderate risk
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