Recalls / Class III
Class IIID-0766-2016
Product
Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102
- Brand name
- Scrub-stat
- Generic name
- Chlorhexidine Gluconate
- Active ingredient
- Chlorhexidine Gluconate
- Route
- Topical
- NDC
- 47593-468
- FDA application
- NDA019258
- Affected lot / code info
- Lot #: a) L041051, Exp 04 /17; L060151, L061951, Exp 06 /17; b) L060151, L061951, Exp 06 /17
Why it was recalled
Subpotent drug
Recalling firm
- Firm
- Ecolab Inc
- Manufacturer
- Ecolab Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 370 Wabasha St N, N/A, Saint Paul, Minnesota 55102-1323
Distribution
- Quantity
- 706 bottles
- Distribution pattern
- Nationwide, Puerto Rico and Canada
Timeline
- Recall initiated
- 2016-02-12
- FDA classified
- 2016-03-08
- Posted by FDA
- 2016-03-16
- Terminated
- 2017-03-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0766-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.