- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionDue to Possible Microbial Contamination
- Company Name:
- Beaumont Bio Med, Inc.
- Brand Name:
Brand Name(s)Beaumont Bio Med Homeopathic
- Product Description:
Product DescriptionHomeopathic oral sprays
Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.
Risk Statement: The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. To date, Beaumont Bio Med has not received any reports of adverse events related to this recall.
The products being recalled are listed in this table:
|Products Name||Size/Packaging/Dosage Form||NDC Number||Lot Number||Expire Date|
|Skin Irritation & Itch Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7002 7||091515C||09/2018|
|Skin Irritation & Itch Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7002 7||050118S||05/2021|
|Sinus Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7013 7||100316A||10/2109|
|SoreThroat & Laryngitis Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7014 7||100316G||10/2019|
|SoreThroat & Laryngitis Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7014 7||050118R||05/2021|
|Diarrhea Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7022 7||090915||09/2018|
|Muscle & Joint Pain Relief||2 Fl Oz, Amber Glass, Oral Spray||58066 7041 7||012916F||01/2019|
|Allergy & Hay Fever Relief||2 Fl Oz, Amber Glass, Oral Spray||58066 7011 7||050216X||05/2019|
|Cold & Flu Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7012 7||042816C||04/2019|
|Cold & Flu Response||2 Fl Oz, Amber Glass, Oral Spray||58066 7012 7||112317K||11/2020|
|Arthritis Pain Relief||2 Fl Oz, Amber Glass, Oral Spray||58066 7042 7||112317K||01/2019|
Beaumont Bio Med Homeopathic Medicines are distributed Nationwide in the USA to wholesalers, health professionals and retail establishments and on our website www.naturalief.com
Beaumont Bio Med is notifying its distributors and customers by email and/or phone and is arranging for return/replacement/refund of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using, discard or return to place of purchase for replacement or refund.
Consumers with questions regarding this recall can contact Beaumont Bio Med by phone : 800-332-2249 or e-mail: firstname.lastname@example.org on Monday – Friday from 8:30AM to 4:00PM, CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Company Contact Information
- Beaumont Bio Med