Recalls / Class II
Class IID-0231-2017
Product
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
- Brand name
- Chlorhexidine Gluconate
- Generic name
- Chlorhexidine Gluconate
- Active ingredient
- Chlorhexidine Gluconate
- Route
- Topical
- NDC
- 53462-705
- FDA application
- NDA021669
- Affected lot / code info
- Lot #: a) 50749, Exp. 9/29/16; 50765, Exp. 9/30/16; 50771, Exp. 9/30/16; 50773, Exp. 10/01/16; 52839, Exp. 2/9/17; 52843, Exp. 2/9/17; 52855, Exp. 2/10/17; 52861, Exp. 2/10/17; 53840, Exp. 4/21/17; 56081, Exp. 9/1/17; 56513, Exp. 9/26/17; b) 54760, Exp. 6/15/17; c) 54763, Exp. 6/16/17 a) Lot # 50749 , Exp. 9/29/2016 ; Lot # 50765 , Exp. 9/30/2016 ; Lot # 50771 , Exp. 9/30/2016 ; Lot # 50773 , Exp. 10/1/2016 ; Lot # 52839 , Exp. 2/9/2017 ; Lot # 52843 , Exp. 2/9/2017 ; Lot # 52855 , Exp. 2/10/2017 ; Lot # 52861 , Exp. 2/10/2017 ; Lot # 53840 , Exp. 4/21/2017 . b) Lot # 54763, Exp. 6/16/2017. c) Lot # 54760, Exp. 6/15/2017.
Why it was recalled
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Recalling firm
- Firm
- Sage Products LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3909 3 Oaks Rd, N/A, Cary, Illinois 60013-1804
Distribution
- Quantity
- 2756 cases
- Distribution pattern
- Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Timeline
- Recall initiated
- 2016-07-29
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0231-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.