Sage Products Recalls Chlorhexidine Gluconate Cloth Due to CGMP Deviations
Sage Products LLC is recalling 2% Chlorhexidine Gluconate Cloth due to CGMP deviations and potential contamination. The product was distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text cites CGMP deviations and potential contamination without reporting specific illnesses or injuries, aligning with a moderate severity rating for a precautionary recall.
Plain-English summary
Sage Products LLC is recalling 2% Chlorhexidine Gluconate Cloth, a topical antiseptic product. The recall involves 2,756 cases of the product, which is packaged as 2 disposable cloths per package and further packaged into 96 packages per case. The product is labeled with Reorder #9705, #9701-P, and #9780, and carries the NDC 53462-705-20.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. These deviations create a risk of potential contamination in products manufactured on the same equipment and lines as the contaminated product. The affected lots include specific expiration dates ranging from September 2016 to September 2017.
The product was distributed nationwide, as well as in Puerto Rico, the United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, the UK, Honduras, Ireland, Mexico, Malaysia, the Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE)
- Brand
- CHLORHEXIDINE GLUCONATE
- Manufacturer
- Sage Products LLC
- Category
- Drug — Topical Antiseptic
- Affected units
- 2,756
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: a) 50749
- Exp. 9/29/16
- 50765
- Exp. 9/30/16
- 50771
- 50773
- Exp. 10/01/16
- 52839
- Exp. 2/9/17
- 52843
- 52855
- Exp. 2/10/17
- 52861
- 53840
- Exp. 4/21/17
- 56081
- Exp. 9/1/17
- 56513
- Exp. 9/26/17
- b) 54760
UPCs (1)
- 0618029850607
Distribution
Part of a larger recall action
This product is one of 3 recalled by Sage Products LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · CHLORHEXIDINE GLUCONATE
- HighXttrium Recalls Chlorhexidine Gluconate Oral Rinse Due to CGMP Deviations
FDA (Drugs) · 2017-07-12
Same manufacturer · Sage Products LLC
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- ModerateSage Products Recalls Comfort Shield Barrier Cream Cloths Due to CGMP Deviations
FDA (Drugs) · 2016-12-28
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