Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
National Drug Code
Is NDC 54365-0400-34 recalled?
ChloraPrep One-Step · 25 POUCH in 1 CARTON (54365-400-34) / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR
Yes — this exact package was recalled
1 FDA recall names the code 54365-0400-34 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
16 of these recalls are still ongoing.
- Active ingredient
- chlorhexidine gluconate and isopropyl alcohol
- Strength
- CHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mL
- Form
- Solution · Topical
- Labeler
- CareFusion 213, LLC
- Type
- Human OTC Drug
- Product code
- 54365-0400
Recalls naming this package
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
ChloraPrep FREPP
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Clear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class I · High risk
BD ChloraPrep FREPP Clear
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class I · High risk
BD ChloraPrep Clear
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II · Moderate risk
BD ChloraPrep FREPP Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class I · High risk
BD ChloraPrep Clear 1mL Applicators
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class II · Moderate risk
BD ChloraPrep Clear
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.
Class I · High risk
BD ChloraPrep Hi-Lite Orange 26 mL Applicator
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Non-sterility.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.
Class I · High risk
BD ChloraPrep Clear
Non-sterility.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.
Class I · High risk
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
BD ChloraPrep Clear
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
BD ChloraPrep Clear 3 mL Applicators
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class II · Moderate risk
ChloraPrep One-Step
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 54365-0014 PurPrep 3
- 54365-0145 See recall 1
- 54365-0151 See recall 1
- 54365-0161 See recall 1
- 54365-0170 See recall 1
- 54365-0200 See recall 1
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