Drug product
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
D-1427-2015
Product summary
- Firm
- Healthpoint, Ltd
- Event
- Event 72039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,910 bottles
- Official record key
drug-enforcement:D-1427-2015
Official wording
Reason: Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Code information: Lot #: GBDM, Exp 1/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination