Why it was recalled
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Product description
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013
Lot numbers, UPCs & expiration codes
Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1573-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 27, 2014
- FDA report date
- Sep 10, 2014
- Quantity
- 8-ct. 7,066 cases; 24-ct. 2,664 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sage Products Inc
Original FDA data
Every field from FDA enforcement report D-1573-2014, exactly as published.
Show all FDA fields
- City
- Cary
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69141
- Address
- 3909 3 Oaks Rd
- Code information
- Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
- Postal code
- 60013-1804
- Report date
- Sep 10, 2014
- Product type
- Drugs
- Recall number
- D-1573-2014
- Classification
- Class II
- Recalling firm
- Sage Products Inc
- Product quantity
- 8-ct. 7,066 cases; 24-ct. 2,664 cases
- Termination date
- Feb 8, 2016
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 27, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 3, 2014