CLASS II Drug recall · Reported 26 Sep 2018 · FDA Enforcement Report
Skin Irritation & Itch Response Homeopathic Formula per amber recalled
Beaumont Bio-med is recalling Skin Irritation & Itch Response Homeopathic Formula per amber, distributed nationwide in the US. The recall was initiated on 31 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1192-2018
- FDA event ID
- 80963
- Recalling firm
- Beaumont Bio-med, Waukon, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2018
- FDA classified
- 17 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 31 Aug 2018 | Recall initiated by company | |
| 17 Sep 2018 | Classified by FDA | +17 days |
| 26 Sep 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Which lots are affected?
Lot: 091515C, Exp 09/2018; 050118S, Exp 05/2021
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 80963| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Diarrhea Response Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide | |
| CLASS II | Allergy & Hay Fever Relief Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide | |
| CLASS II | Sinus Response Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide | |
| CLASS II | Colds & Flu Response Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide | |
| CLASS II | Arthritis Pain Relief Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide | |
| CLASS II | Muscle & Joint Pain Relief Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide | |
| CLASS II | Sore Throat & Laryngitis Response Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide |
More recalls from Beaumont Bio-med
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sore Throat & Laryngitis Response Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide |
| Drug | CLASS II | Muscle & Joint Pain Relief Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide |
| Drug | CLASS II | Arthritis Pain Relief Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide |
| Drug | CLASS II | Colds & Flu Response Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide |
| Drug | CLASS II | Sinus Response Homeopathic Formula per amber recalled | Beaumont Bio-med | Sterility | Nationwide |