Why it was recalled
Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Product description
Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11
Lot numbers, UPCs & expiration codes
Lot #: GBDM, Exp 1/2016
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-1427-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2015
- FDA report date
- Sep 16, 2015
- Quantity
- 11,910 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Healthpoint, Ltd
Original FDA data
Every field from FDA enforcement report D-1427-2015, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72039
- Address
- 3909 Hulen St
- Code information
- Lot #: GBDM, Exp 1/2016
- Postal code
- 76107-7253
- Report date
- Sep 16, 2015
- Product type
- Drugs
- Recall number
- D-1427-2015
- Classification
- Class II
- Recalling firm
- Healthpoint, Ltd
- Product quantity
- 11,910 bottles
- Termination date
- Nov 17, 2016
- Reason for recall
- Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 4, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 10, 2015