FDA Drug recall D-0231-2017
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705…
- FDA Drug
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705… by Sage Products, citing CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0231-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-29 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sage Products |
| Distribution | US |
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.
Reason
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Identifiers
| ndc | 53462-705-20 |
|---|---|
| ndc | 53462-705-23 |
| ndc | 53462-705-26 |
| 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; 5284…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0231-2017%22
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