CHLORHEXIDINE GLUCONATE 1.2 mg/mL

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