CHLORHEXIDINE GLUCONATE 40 mg/mL
chlorhexidine gluconate · SOLUTION · Rising Pharma Holdings, Inc.
CHLORHEXIDINE GLUCONATE is a solution containing chlorhexidine gluconate at 40 mg/mL, taken topical. Manufactured by Rising Pharma Holdings, Inc..
Key Facts
- Brand Name
- CHLORHEXIDINE GLUCONATE
- Generic Name
- chlorhexidine gluconate
- NDC Code (Product)
16571-111- Manufacturer
- Rising Pharma Holdings, Inc.
- Strength
- 40 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA019258
- Marketing Start
- 07/26/2023
Recall History
Sage Products Inc
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
CareFusion 213, LLC
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
CareFusion 213, LLC
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
CareFusion 213, LLC
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Akorn, Inc.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Akorn, Inc.
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Sage Products LLC
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Akorn, Inc.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Sage Products Inc
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Sunstar Americas, Inc.
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Frequently Asked Questions
What is CHLORHEXIDINE GLUCONATE used for?
CHLORHEXIDINE GLUCONATE contains chlorhexidine gluconate. It is a solution taken topical. Consult your doctor for specific uses.
Is CHLORHEXIDINE GLUCONATE a controlled substance?
CHLORHEXIDINE GLUCONATE is not classified as a controlled substance by the DEA.
What is the generic name for CHLORHEXIDINE GLUCONATE?
The generic name for CHLORHEXIDINE GLUCONATE is chlorhexidine gluconate. There are 11 other brand versions of chlorhexidine gluconate.
What is the NDC code for CHLORHEXIDINE GLUCONATE 40 mg/mL?
The NDC (National Drug Code) for CHLORHEXIDINE GLUCONATE 40 mg/mL is 16571-111, listed by Rising Pharma Holdings, Inc..
Other CHLORHEXIDINE GLUCONATE Dosages
Other Chlorhexidine Brands
See all →- Bactoshield CHG Chlorhexidine Gluconate20 mg/mL11084-038
- Bactoshield CHG40 mg/mL11084-039
- Antiseptic Solution4 g/100mL11701-172
- Halyard Chlorhexidine Gluconate40 mg/mL39892-0960
- ReadyPrep CHG500 mg/153329-244
- NUPRO Chlorhexidine Gluconate1.2 mg/mL65222-800
- Chlorhexidine Gluconate1.2 mg/mL66975-600
- Chlorhexidine Gluconate1.2 mg/mL70518-4494
- Antimicrobial Foam Handwash20 mg/mL21749-416
- Antiseptic Foam Handwash20 mg/mL21749-461
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)