Xttrium Recalls Chlorhexidine Gluconate Oral Rinse Due to CGMP Deviations
Xttrium Laboratories is voluntarily recalling 36,720 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse due to Current Good Manufacturing Practice (CGMP) deviations.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source cites CGMP deviations as the cause, which falls under the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the text.
Plain-English summary
Xttrium Laboratories, Inc. is voluntarily recalling 36,720 16-ounce glass bottles of Chlorhexidine Gluconate 0.12% Oral Rinse, USP. The product is a prescription-only oral rinse distributed nationwide. The recall was initiated on June 1, 2017, and was classified as Class II by the FDA.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots are 704-201 (full lot # 704-1999-201) with an expiration date of 03/20, and 705-208 (full lot # 705-1999-208) with an expiration date of 04/20. The product is identified by NDC 0116-2001-16.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The recall status is currently terminated.
The recalled product
- Product
- CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE)
- Brand
- CHLORHEXIDINE GLUCONATE
- Manufacturer
- Xttrium Laboratories Inc
- Category
- Drug — Oral Rinse
- Hazard
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 (3)
- 1999CHG16MC-Lot number 704-201 (full lot # 704-1999-201)
- Exp 03/20 1999CHG16MC-Lot number 705-208 (full lot # 705-1999-208)
- Exp 04/20
UPCs (1)
- 0301162001158
Distribution
Distribution scope not specified by the agency.
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