The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0231-2017·Announced 2016-12-28

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

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