Drug recall: NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical…
Class II FDA enforcement event 91708. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Nutraceutical Corporation started this drug recall on 23 Feb 2023. The firm address in the FDA record is in Park City, UT. FDA put the recall in Class II. FDA event 91708 has 4 product records. The first FDA enforcement report date is 15 Mar 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA.
Recalling firm
Nutraceutical Corporation, Park City, UT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0437-2023 | NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9 | 13,974 | Class II | Ongoing | 15 Mar 2023 |
| D-0438-2023 | NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2 | 4004 | Class II | Ongoing | 15 Mar 2023 |
| D-0439-2023 | NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA | 8,146 | Class II | Ongoing | 15 Mar 2023 |
| D-0440-2023 | NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0 | 1590 | Class II | Ongoing | 15 Mar 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2023
- 281
- Share of these events in Class II
- 59%
- Product records in this event
- 4
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0437-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 91708. https://recallregister.com/fda/ii/91708/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA.
- What quantity of product is in FDA event 91708?
- The event has 4 product records. The first record gives this quantity:
13,974
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2023 have the same class?
- 59% of the 281 drug events that started in 2023 are in Class II.