Class II · Moderate risk
Comfort Shield
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
National Drug Code
Is NDC 53462-0915-81 recalled?
Comfort Shield Barrier
Yes — this exact package was recalled
1 FDA recall names the code 53462-0915-81 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- dimethicone
- Strength
- DIMETHICONE 30 mg/g
- Form
- Cloth · Topical
- Labeler
- Sage Products LLC
- Type
- Human OTC Drug
- Product code
- 53462-0915
Recalls naming this package
Class I · High risk
Comfort Shield
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class II · Moderate risk
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 53462-0705 Chlorhexidine Gluconate 2
- 53462-0024 See recall 1
- 53462-0922 See recall 1
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