Food recall: Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
Class II FDA enforcement event 89512. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
cGMP Deviations
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
ULTRAtab Laboratories, Inc. started this food recall on 6 Oct 2021. The firm address in the FDA record is in Highland, NY. FDA put the recall in Class II. FDA event 89512 has 9 product records. The first FDA enforcement report date is 16 Feb 2022. The record gives the status Terminated, with the termination date 1 Sep 2022.
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.
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Recalling firm
ULTRAtab Laboratories, Inc., Highland, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0721-2022 | Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY | 4,250,842 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0722-2022 | Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY | 26,682,419 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0723-2022 | Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY | 1,904,760 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0724-2022 | Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY | 1,606,966 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0725-2022 | Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY | 1,393,353 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0726-2022 | Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY | 955,928 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0727-2022 | Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY | 5,853,539 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0728-2022 | Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY | 1,478,344 tablets | Class II | Terminated | 16 Feb 2022 |
| F-0729-2022 | MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY | 42,352,387 tablets | Class II | Terminated | 16 Feb 2022 |
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
- Food events that started in 2021
- 463
- Share of these events in Class II
- 57%
- Product records in this event
- 9Median of the firm: 9
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Jan 2022 | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laborat | Drug | Class II | 33 |
| 29 Nov 2021 | PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated | Drug | Class II | 1 |
Official channels
- FDA enforcement report F-0721-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 89512. https://recallregister.com/fda/ii/89512/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food 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:
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
- What quantity of product is in FDA event 89512?
- The event has 9 product records. The first record gives this quantity:
4,250,842 tablets
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2021 have the same class?
- 57% of the 463 food events that started in 2021 are in Class II.