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.
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:
Product Names | 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 |
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Skin Irritation & Itch Response | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7002 7 |
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Sinus Response | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7013 7 | 100316A |
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SoreThroat & Laryngitis Response | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7014 7 | 100316G |
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SoreThroat & Laryngitis Response | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7014 7 | 050118R |
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Diarrhea Response | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7022 7 | 090915 |
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Muscle & Joint Pain Relief | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7041 7 | 012916F |
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Allergy & Hay Fever Relief | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7011 7 | 050216X |
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Cold & Flu Response | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7012 7 | 042816C |
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Cold & Flu Response | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7012 7 | 112317K |
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Arthritis Pain Relief | 2 Fl Oz, Amber Glass, Oral Spray | 58066 7042 7 | 112317K |
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(Source: The U.S. Food and Drug Administration)