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.
Reported: December 28, 2016 Initiated: July 29, 2016 #D-0231-2017
Product Description
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 for Recall
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Details
- Recalling Firm
- Sage Products LLC
- Units Affected
- 2756 cases
- Distribution
- Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
- Location
- Cary, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sage Products LLC. Units affected: 2756 cases.
Why was this product recalled? ▼
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Moderate. Recall number: D-0231-2017.
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