Drug recall: 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab…
Class II FDA enforcement event 89334. 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 drug recall on 26 Jan 2022. The firm address in the FDA record is in Highland, NY. FDA put the recall in Class II. FDA event 89334 has 33 product records. The first FDA enforcement report date is 16 Feb 2022. The record gives the status Terminated, with the termination date 7 Jan 2025.
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 3 distributors who may have 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
33 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0523-2022 | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00 | 33,758,436 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0524-2022 | 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00 | 19,103,287 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0525-2022 | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx | 1,798,048 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0526-2022 | Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00 | 639,729 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0527-2022 | Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00 | 917,304 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0528-2022 | Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00 | 14,566,510 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0529-2022 | APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00 | 451,123 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0530-2022 | APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00 | 14,349,148 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0531-2022 | APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00 | 3,677,483 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0532-2022 | Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00 | 16,429,211 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0533-2022 | Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00 | 3,667,885 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0534-2022 | Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00 | 2,048,941 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0535-2022 | Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00 | 6,215,512 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0536-2022 | APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00 | 6,249,082 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0537-2022 | APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00 | 18,772,640 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0538-2022 | HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00 | 50,585,623 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0539-2022 | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00 | 3,349,387 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0540-2022 | Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00 | 3,052,313 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0541-2022 | Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00 | 3,050,308 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0542-2022 | Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00 | 1,527,203 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0543-2022 | Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00 | 5,923,518 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0544-2022 | Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00 | 7,297,709 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0545-2022 | Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00 | 4,531,580 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0546-2022 | Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00 | 7,983,360 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0547-2022 | Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00 | 990,197 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0548-2022 | APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00 | 6,380,282 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0549-2022 | Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00 | 452,038 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0550-2022 | Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00 | 1,585,375 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0551-2022 | Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00 | 1,477,641 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0552-2022 | Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00 | 14,066,434 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0553-2022 | Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00 | 25,769,495 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0554-2022 | DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00 | 8,727,657 tablets | Class II | Terminated | 16 Feb 2022 |
| D-0555-2022 | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00 | 37,464,418 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
- Drug events that started in 2022
- 325
- Share of these events in Class II
- 65%
- Product records in this event
- 33Median of the firm: 9
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 6 Oct 2021 | Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY | Food | Class II | 9 |
Official channels
- FDA enforcement report D-0523-2022The 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 89334. https://recallregister.com/fda/ii/89334/. 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:
Bulk product was distributed to 3 distributors who may have distributed finished product.
- What quantity of product is in FDA event 89334?
- The event has 33 product records. The first record gives this quantity:
33,758,436 tablets
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2022 have the same class?
- 65% of the 325 drug events that started in 2022 are in Class II.