Ultra Seal

66 recalls •

💊 Drugs

• Categories: Prescription Drugs, Other Drugs

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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.

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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.

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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.

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Other Drugs Nationwide View Details →

MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Other Drugs Nationwide View Details →

MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Other Drugs Nationwide View Details →

MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040

Class I - Dangerous

cGMP deviations

Jan 24, 2022 Prescription Drugs Nationwide View Details →

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Oct 13, 2021 Prescription Drugs Nationwide View Details →

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Aug 3, 2020 Prescription Drugs View Details →

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,

Class I - Dangerous

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Aug 3, 2020 Prescription Drugs View Details →