Class II · Moderate risk Ongoing
BD ChloraPrep Clear
Reason Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
R2103
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products were not manufactured under current good manufacturing practices.
What was recalled
R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
- Recalling firm
- Washington Homeopathic Products, Inc.
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0506-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Alcohol recalls
See all
Class I · High risk Ongoing
Glutathione
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class II · Moderate risk Ongoing
BD ChloraPrep CLear
Reason 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 Ongoing
BD ChloraPrep CLear
Reason 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 Ongoing
BD ChloraPrep Scrub Teal
Reason 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
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.