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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92917

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 25, 2023
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
CareFusion 213, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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).

D-1168-2023
Recall number
D-1168-2023
Initiated
August 25, 2023
Classification
Class II
Status
Completed
Recalling firm
CareFusion 213, LLC
Quantity
398,160 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Stability data does not support expiry

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025

Distribution pattern

Distributed nationwide to 100 consignees. Please refer to consignee list.