CareFusion 213, LLC Recall: BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and
CareFusion 213, LLC Recall: BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: CareFusion 213, LLC; Product: BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL
| Recalling firm | CareFusion 213, LLC |
|---|---|
| Product | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case). |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Completed |
| Distribution | Distributed nationwide to 100 consignees. Please refer to consignee list. |
| Recall initiated | 20230825 |
| Recall number | D-1168-2023 |
| Category | drug |
| State | TX |
| Country | United States |
$29/mo
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