Drug recall: Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH…
Class II FDA enforcement event 89464. 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
Ultra Seal Corporation started this drug recall on 24 Jan 2022. The firm address in the FDA record is in New Paltz, NY. FDA put the recall in Class II. FDA event 89464 has 56 product records. The first FDA enforcement report date is 9 Feb 2022. The record gives the status Terminated, with the termination date 16 Oct 2023.
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 within the United States
Recalling firm
Ultra Seal Corporation, New Paltz, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
56 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0464-2022 | Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040 | 3,508,200 packets | Class II | Terminated | 9 Feb 2022 |
| D-0465-2022 | Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040 | 313,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0466-2022 | AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 | 226,390 packets | Class II | Terminated | 9 Feb 2022 |
| D-0467-2022 | Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68 | 1,236,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0468-2022 | CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2 | 225,350 packets | Class II | Terminated | 9 Feb 2022 |
| D-0469-2022 | Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc. | 297,050 packets | Class II | Terminated | 9 Feb 2022 |
| D-0470-2022 | Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50 | 174,852 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0471-2022 | Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40 | a) 702,240 blisters, b) 30,180 blisters | Class II | Terminated | 9 Feb 2022 |
| D-0472-2022 | DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270 | a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets | Class II | Terminated | 9 Feb 2022 |
| D-0473-2022 | Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24 | 301,842 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0474-2022 | Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02 | a) 9,060 bottles, b) 44,700 packets | Class II | Terminated | 9 Feb 2022 |
| D-0475-2022 | MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA | 2,189,232 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0476-2022 | Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00 | 1,959,267 packets | Class II | Terminated | 9 Feb 2022 |
| D-0477-2022 | Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | 915,770 packets | Class II | Terminated | 9 Feb 2022 |
| D-0478-2022 | Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | 673,160 packets | Class II | Terminated | 9 Feb 2022 |
| D-0479-2022 | Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487 | 25,776 blisters | Class II | Terminated | 9 Feb 2022 |
| D-0480-2022 | Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 | 227,010 packets | Class II | Terminated | 9 Feb 2022 |
| D-0481-2022 | Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040 | 1,351,660 packets | Class II | Terminated | 9 Feb 2022 |
| D-0482-2022 | Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832 | 5,107,565 packets | Class II | Terminated | 9 Feb 2022 |
| D-0483-2022 | Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03 | 7,858,690 packets | Class II | Terminated | 9 Feb 2022 |
| D-0484-2022 | Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02 | 5,741,384 packets | Class II | Terminated | 9 Feb 2022 |
| D-0485-2022 | Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040 | 1,186,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0486-2022 | Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040 | 301,650 packets | Class II | Terminated | 9 Feb 2022 |
| D-0487-2022 | COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556 | 226,400 packets | Class II | Terminated | 9 Feb 2022 |
| D-0488-2022 | PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507 | 1,188,280 packets | Class II | Terminated | 9 Feb 2022 |
| D-0489-2022 | SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00 | 122,400 packets | Class II | Terminated | 9 Feb 2022 |
| D-0490-2022 | DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03 | 2,685,700 packets | Class II | Terminated | 9 Feb 2022 |
| D-0491-2022 | EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03 | 1,694,200 packets | Class II | Terminated | 9 Feb 2022 |
| D-0492-2022 | PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040 | 2,336,600 packets | Class II | Terminated | 9 Feb 2022 |
| D-0493-2022 | PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00 | 111,300 packets | Class II | Terminated | 9 Feb 2022 |
| D-0494-2022 | PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03 | 769,200 packets | Class II | Terminated | 9 Feb 2022 |
| D-0495-2022 | CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040 | 447,050 packets | Class II | Terminated | 9 Feb 2022 |
| D-0496-2022 | Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68 | 1,309,800 packets | Class II | Terminated | 9 Feb 2022 |
| D-0497-2022 | Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68 | 887,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0498-2022 | Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00 | 1,180,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0499-2022 | PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423 | 533,100 packets | Class II | Terminated | 9 Feb 2022 |
| D-0500-2022 | MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423 | 307,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0501-2022 | PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. | N/A | Class II | Terminated | 9 Feb 2022 |
| D-0502-2022 | PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. | a)131,112 packets, b) 8,064 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0503-2022 | PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. | a) 113,040 packets, b) 7,132 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0504-2022 | PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. | a) 156,096 packets, b) 9,648 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0505-2022 | CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895 | 241,560 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0506-2022 | MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6 | 90,072 bottles | Class II | Terminated | 9 Feb 2022 |
| D-0507-2022 | Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124 | 1,1401,641 packets | Class II | Terminated | 9 Feb 2022 |
| D-0508-2022 | Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | 1,486,050 packets | Class II | Terminated | 9 Feb 2022 |
| D-0509-2022 | FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | 223,090 packets | Class II | Terminated | 9 Feb 2022 |
| D-0510-2022 | CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | 225,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0511-2022 | CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | 1,019,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0512-2022 | AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | 216,000 packets | Class II | Terminated | 9 Feb 2022 |
| D-0513-2022 | SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | 448,300 packets | Class II | Terminated | 9 Feb 2022 |
| D-0514-2022 | MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | 409,890 packets | Class II | Terminated | 9 Feb 2022 |
| D-0515-2022 | ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | 1,474,050 packets | Class II | Terminated | 9 Feb 2022 |
| D-0516-2022 | REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487 | a) 308,928 blisters b) 29,808 blisters | Class II | Terminated | 9 Feb 2022 |
| D-0517-2022 | REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487 | 40,344 blisters | Class II | Terminated | 9 Feb 2022 |
| D-0518-2022 | Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 | 447,190 packets | Class II | Terminated | 9 Feb 2022 |
| D-0519-2022 | Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 | 227,010 packets | Class II | Terminated | 9 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
- 56Median of the firm: 8
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Oct 2021 | PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case | Drug | Class III | 8 |
| 3 Aug 2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufac | Drug | Class III | 2 |
Official channels
- FDA enforcement report D-0464-2022The 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 89464. https://recallregister.com/fda/ii/89464/. 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 within the United States
- What quantity of product is in FDA event 89464?
- The event has 56 product records. The first record gives this quantity:
3,508,200 packets
- 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.