Drug recall: Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC…
Class II FDA enforcement event 81218. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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
Sprayology started this drug recall on 9 Oct 2018. The firm address in the FDA record is in Gaithersburg, MD. FDA put the recall in Class II. FDA event 81218 has 22 product records. The first FDA enforcement report date is 7 Nov 2018. The record gives the status Terminated, with the termination date 18 Apr 2019.
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.
Distributed Nationwide in the USA
Recalling firm
Sprayology, Gaithersburg, MD.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
22 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0105-2019 | Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1 | 1,558 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0106-2019 | Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1 | 830 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0107-2019 | Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1 | 2,054 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0108-2019 | Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1 | 1,284 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0109-2019 | MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0014-1 and Tester NDC 61096-1014 | 2,301 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0110-2019 | Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1 | 731 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0111-2019 | AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1 | 4,153 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0112-2019 | Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1 | 2,565 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0113-2019 | DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1 | 1,465 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0114-2019 | SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1 | 5,393 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0115-2019 | TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1 | 1,307 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0116-2019 | Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1 | 2,956 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0117-2019 | Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1 | 3,531 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0118-2019 | Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1 | 1,055 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0119-2019 | Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0006-1 and Tester NDC 61096-1006-1 | 3,896 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0120-2019 | PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1 | 647 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0121-2019 | Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-0023-1 and Tester NDC 61096-1023-1 | 1,473 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0122-2019 | ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1 | 2,837 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0123-2019 | Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1 | 857 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0124-2019 | Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1 | 919 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0125-2019 | Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1 | 2,595 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0126-2019 | Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0004-1 | 3634 bottles | Class II | Terminated | 7 Nov 2018 |
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 2018
- 367
- Share of these events in Class II
- 60%
- Product records in this event
- 22
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0105-2019The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 81218. https://recallregister.com/fda/ii/81218/. 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:
Distributed Nationwide in the USA
- What quantity of product is in FDA event 81218?
- The event has 22 product records. The first record gives this quantity:
1,558 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 60% of the 367 drug events that started in 2018 are in Class II.