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FDA · Drug recall

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per… and 55 more products

Feb. 9, 2022 Class II

Date
Feb. 9, 2022
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): 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)
Status
Terminated
Filed by
Ultra Seal Corporation
Reason
cGMP deviations
Distribution pattern
Nationwide within the United States

56 products in this recall

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet…

Product
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
Quantity
3,508,200 packets
Codes and lots
Lot #: AK9491, AK9496, Exp. Date 02/2022; K9817, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0464-2022

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg…

Product
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
Quantity
313,000 packets
Codes and lots
Lot #: K9824, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0465-2022

AERO TAB Cold Relief (acetaminophen 325 mg…

Product
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
Quantity
226,390 packets
Codes and lots
Lot #: AK9565, Exp. Date 04/2022
Recall started
Jan. 24, 2022
Recall number
D-0466-2022

Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets…

Product
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
Quantity
1,236,000 packets
Codes and lots
Lot #: AK9495, Exp. Date 02/2022; AK9613, Exp. Date 05/2022
Recall started
Jan. 24, 2022
Recall number
D-0467-2022

CHLORESIN (acetaminophen 325mg…

Product
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
Quantity
225,350 packets
Codes and lots
Lot #: AK9492, Exp. Date 02/2022
Recall started
Jan. 24, 2022
Recall number
D-0468-2022

Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets…

Product
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
Quantity
297,050 packets
Codes and lots
Lot #: AK9602, Exp. Date 05/2022
Recall started
Jan. 24, 2022
Recall number
D-0469-2022

Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg…

Product
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
Quantity
174,852 bottles
Codes and lots
Lot #: HY9042, Exp. Date 02/2022; HY9094, HY9112, Exp. Date 04/2022; HY9134, Exp. Date 05/2022; HY9267, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0470-2022

Cystex Urinary Pan Relief (NSAID) (methenamine 162mg…

Product
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
Quantity
a) 702,240 blisters, b) 30,180 blisters
Codes and lots
Lot #: a) 19A043, 19A093, Exp. Date 01/2022; 19B062,19C079,19C080, Exp. Date 03/2022; 19D041, Exp. Date 04/2022; 19E035, 19E087, Exp. Date 05/2022; 19G084, Exp. Date 08/2022; 19H098, Exp. Date 09/2022 b) 19H098A, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0471-2022

DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets…

Product
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
Quantity
a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets
Codes and lots
Lot #: a) C19065, Exp. Date 03/2022; F19081, Exp. Date 06/2022; 19H083, Exp. Date 08/2022; b) H19083, 1H9083, Exp. Date 08/2022; c) 19F081, Exp. Date 06/2022; 19083H, Exp. Date 08/2022; d) 19C065, Exp. Date 03/2022; 19081F, Exp. Date 06/2022
Recall started
Jan. 24, 2022
Recall number
D-0472-2022

Ephedrine Plus (Ephedrine HCl 25mg…

Product
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
Quantity
301,842 bottles
Codes and lots
Lot#: 18M063, Exp. Date 01/2022; 19G076, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0473-2022

Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets…

Product
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
Quantity
a) 9,060 bottles, b) 44,700 packets
Codes and lots
Lot #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022
Recall started
Jan. 24, 2022
Recall number
D-0474-2022

MidNite Sleep Health (melatonin 1.5 mg) tablets…

Product
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
Quantity
2,189,232 bottles
Codes and lots
Lot #: 18L124, 18L125, 18L126, Exp. Date 02/2022; 19C037, 19C038, 19C039, 19C040, Exp. Date 03/2022; 19D029, 19D030, Exp. Date 04/2022; 19D031, Exp. Date 06/2022; 19G047, Exp. Date 07/2022
Recall started
Jan. 24, 2022
Recall number
D-0475-2022

Back Pain-Off (caffeine 50mg…

Product
Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
Quantity
1,959,267 packets
Codes and lots
Lot #: 9708, Exp. Date 07/2022; AK9810, Exp. Date 09/2022; AK9946, K9946, Exp. Date 12/2022
Recall started
Jan. 24, 2022
Recall number
D-0476-2022

Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets…

Product
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Quantity
915,770 packets
Codes and lots
Lot #: A-K-9668, Exp. Date 06/2022; A-K-9475, Exp. Date 02/2022
Recall started
Jan. 24, 2022
Recall number
D-0477-2022

Multi Symptom Cold Relief (acetaminophen 325 mg…

Product
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
Quantity
673,160 packets
Codes and lots
Lot #: AK9715, K9715, Exp. Date 07/2022
Recall started
Jan. 24, 2022
Recall number
D-0478-2022

Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets…

Product
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
Quantity
25,776 blisters
Codes and lots
Lot #: 19E058A, 19E058B, Exp. Date 05/2022
Recall started
Jan. 24, 2022
Recall number
D-0479-2022

Cold Relief Severe Pain/Cough (acetaminophen 325mg…

Product
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
Quantity
227,010 packets
Codes and lots
Lot #: AK9436, Exp. Date 01/2022
Recall started
Jan. 24, 2022
Recall number
D-0480-2022

Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg)…

Product
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
Quantity
1,351,660 packets
Codes and lots
Lot #: AK9453, Exp. Date 01/2022; AK9716, 07/2022
Recall started
Jan. 24, 2022
Recall number
D-0481-2022

Backache & Muscle Relief (acetaminophen 250 mg…

Product
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
Quantity
5,107,565 packets
Codes and lots
Lot #: K9770, AK9770 Exp. Date 08/2022; AK9958, K9958 Exp. Date 12/2022; AK9717, Exp. Date 07/2022; AK9522, AK9641 , Exp. Date 03/2022; AK9817, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0482-2022

Cold Relief (acetaminophen 250 mg…

Product
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
Quantity
7,858,690 packets
Codes and lots
Lot #: K9456, AK9454, 9456, AK9456, Exp. Date 01/2022; AK9524, AK9528 Exp. Date 03/2022; K9767, AK9767, Exp. Date 08/2022; AK9824, AK9823, Exp. Date 09/2022; AK9564, Exp. Date 04/2022
Recall started
Jan. 24, 2022
Recall number
D-0483-2022

Headache & Congestion Sinus Relief (acetaminophen 250 mg…

Product
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
Quantity
5,741,384 packets
Codes and lots
Lot #: 9445, AK9445, K9445, Exp. Date 01/2022; K9486, Exp. Date 02/2022; AK9708, Exp. Date 07/2022; AK9515, Exp. Date 03/2022; K9810, Exp. Date 09/2022; AK9658, Exp. Date 06/2022
Recall started
Jan. 24, 2022
Recall number
D-0484-2022

Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg…

Product
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
Quantity
1,186,000 packets
Codes and lots
Lot #: AK9493, Exp. Date 02/2022
Recall started
Jan. 24, 2022
Recall number
D-0485-2022

Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg…

Product
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
Quantity
301,650 packets
Codes and lots
Lot #: K9708, Exp. Date 07/2022
Recall started
Jan. 24, 2022
Recall number
D-0486-2022

COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg…

Product
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
Quantity
226,400 packets
Codes and lots
Lot #: AK9587, Exp. Date 02/2022
Recall started
Jan. 24, 2022
Recall number
D-0487-2022

PAIN TERMINATOR extra strength pain relief (aspirin 162 mg…

Product
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
Quantity
1,188,280 packets
Codes and lots
Lot #: AK9451, Exp. Date 01/2022
Recall started
Jan. 24, 2022
Recall number
D-0488-2022

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg…

Product
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
Quantity
122,400 packets
Codes and lots
Lot #: AK9766, Exp. Date 08/2022
Recall started
Jan. 24, 2022
Recall number
D-0489-2022

Dilotab II…

Product
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
Quantity
2,685,700 packets
Codes and lots
Lot #: AK9548, (L) 106, Exp. Date 04/2022; AK9647, (L)103, Exp. Date 06/2022; AK9598, Exp. Date 05/2022
Recall started
Jan. 24, 2022
Recall number
D-0490-2022

EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets…

Product
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
Quantity
1,694,200 packets
Codes and lots
Lot #: AK9599, Exp. Date 05/2022; AK9648, (L) 104, Exp. Date 06/2022
Recall started
Jan. 24, 2022
Recall number
D-0491-2022

PAINAID (acetaminophen 110 mg…

Product
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Quantity
2,336,600 packets
Codes and lots
Lot #: AK9433, Exp. Date 01/2022; AK9749, Exp. Date 08/2022
Recall started
Jan. 24, 2022
Recall number
D-0492-2022

PAINAID BRF Back Relief Formula (acetaminophen 250 mg…

Product
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
Quantity
111,300 packets
Codes and lots
Lot #: AK9698, Exp. Date 07/2022
Recall started
Jan. 24, 2022
Recall number
D-0493-2022

PAINAID PMF Premenstrual Formula (acetaminophen 500 mg…

Product
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
Quantity
769,200 packets
Codes and lots
Lot #: AK9434, (L)101, Exp. date 01/2022
Recall started
Jan. 24, 2022
Recall number
D-0494-2022

CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets…

Product
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Quantity
447,050 packets
Codes and lots
Lot #: AK9478, Exp. Date 02/2022; AK9799, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0495-2022

Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets…

Product
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
Quantity
1,309,800 packets
Codes and lots
Lot #: AK9523, K9523 Exp. Date 03/2022; AK9670, Exp. Date 06/2022
Recall started
Jan. 24, 2022
Recall number
D-0496-2022

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg…

Product
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
Quantity
887,000 packets
Codes and lots
Lot #: AK9527, Exp. Date 03/2022
Recall started
Jan. 24, 2022
Recall number
D-0497-2022

Regular Strength Pain Reliever (acetaminophen 110 mg…

Product
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
Quantity
1,180,000 packets
Codes and lots
Lot #: AK9450, Exp. Date 01/2022
Recall started
Jan. 24, 2022
Recall number
D-0498-2022

PAPENOL (acetaminophen 500 mg)…

Product
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Quantity
533,100 packets
Codes and lots
Lot #: K9495, Exp. Date 02/2022; AK9614, Exp. Date 05/2022
Recall started
Jan. 24, 2022
Recall number
D-0499-2022

MAGNACAL (calcium carbonate 420 mg)…

Product
MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Quantity
307,000 packets
Codes and lots
Lot #: AK9768, Exp. Date 08/2022
Recall started
Jan. 24, 2022
Recall number
D-0500-2022

PEPTIME Energy (caffeine 250mg) tablets…

Product
PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Quantity
N/A
Codes and lots
Lot #: 19E021, 19E022
Recall started
Jan. 24, 2022
Recall number
D-0501-2022

PEPTIME Energy (caffeine 300mg) tablets…

Product
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.
Quantity
a)131,112 packets, b) 8,064 bottles
Codes and lots
Lot #: a)19E030, b)19E031
Recall started
Jan. 24, 2022
Recall number
D-0502-2022

PEPTIME Energy (caffeine 350mg) tablets…

Product
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.
Quantity
a) 113,040 packets, b) 7,132 bottles
Codes and lots
Lot #: a)19E032, b)19E033
Recall started
Jan. 24, 2022
Recall number
D-0503-2022

PEPTIME Energy (caffeine 250mg) tablets…

Product
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.
Quantity
a) 156,096 packets, b) 9,648 bottles
Codes and lots
Lot #: a)19E021, b)19E022
Recall started
Jan. 24, 2022
Recall number
D-0504-2022

CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)…

Product
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
Quantity
241,560 bottles
Codes and lots
Lot #: 18L124, Exp. Date 02/2022; 19D029, Exp. Date 04/2022
Recall started
Jan. 24, 2022
Recall number
D-0505-2022

MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)…

Product
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
Quantity
90,072 bottles
Codes and lots
Lot #: 19C038C, Exp. Date 03/2022; 19G047C, Exp. Date 07/2022; 18L124C, Exp. Date 02/2022
Recall started
Jan. 24, 2022
Recall number
D-0506-2022

Exaprin pain reliever (acetaminophen 110 mg…

Product
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124
Quantity
1,1401,641 packets
Codes and lots
Lot #: AK9796, Exp. Date 09/2022
Recall started
Jan. 24, 2022
Recall number
D-0507-2022

Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets…

Product
Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Quantity
1,486,050 packets
Codes and lots
Lot #: AK9566, Exp. Date 04/2022; AK9612, Exp. Date 05/2022
Recall started
Jan. 24, 2022
Recall number
D-0508-2022

FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg…

Product
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Quantity
223,090 packets
Codes and lots
Lot #: AK9695, Exp. Date 07/2022
Recall started
Jan. 24, 2022
Recall number
D-0509-2022

CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg…

Product
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
Quantity
225,000 packets
Codes and lots
Lot #: AK9841, Ex. Date 10/2022
Recall started
Jan. 24, 2022
Recall number
D-0510-2022

CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets…

Product
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Quantity
1,019,000 packets
Codes and lots
Lot #: AK9475, Exp. Date 02/2022
Recall started
Jan. 24, 2022
Recall number
D-0511-2022

AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets…

Product
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Quantity
216,000 packets
Codes and lots
Lot #: AK9640, Exp. Date 03/2022
Recall started
Jan. 24, 2022
Recall number
D-0512-2022

SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets…

Product
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Quantity
448,300 packets
Codes and lots
Lot #: AK9859, Exp. Date 10/2022
Recall started
Jan. 24, 2022
Recall number
D-0513-2022

MIRALAC (calcium carbonate 420mg) tablets…

Product
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Quantity
409,890 packets
Codes and lots
Lot #: AK9486, Exp. Date 02/2022
Recall started
Jan. 24, 2022
Recall number
D-0514-2022

ELECTROLYTE Supplement Tablets (calcium 5.2 mg…

Product
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
Quantity
1,474,050 packets
Codes and lots
Lot #: AK9797, AK9254
Recall started
Jan. 24, 2022
Recall number
D-0515-2022

REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets…

Product
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
Quantity
a) 308,928 blisters b) 29,808 blisters
Codes and lots
Lot #: a) 19B050A, 19B050B, 19B050C, 19B050D, 19B050E, Exp. Date 06/2022; 19F063, 19F063A, 19F063B, Exp. Date 08/2022; b) 19B050-A, Exp. Date 06/2022
Recall started
Jan. 24, 2022
Recall number
D-0516-2022

REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets…

Product
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
Quantity
40,344 blisters
Codes and lots
Lot #: 19B011, 19B012, 19B012A, 19E023, Exp. Date 05/2022
Recall started
Jan. 24, 2022
Recall number
D-0517-2022

Sinus Relief (acetaminophen 325mg…

Product
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Quantity
447,190 packets
Codes and lots
Lot #: AK9651, Exp. Date 06/2022; AK9437, Exp. Date 01/2022
Recall started
Jan. 24, 2022
Recall number
D-0518-2022

Sinus Relief Headache/Nasal (acetaminophen 325mg…

Product
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Quantity
227,010 packets
Codes and lots
Lot #: AK9436, Exp. Date 01/2022
Recall started
Jan. 24, 2022
Recall number
D-0519-2022

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement reports, recall numbers D-0464-2022, D-0465-2022, D-0466-2022, D-0467-2022, D-0468-2022, D-0469-2022, D-0470-2022, D-0471-2022 and others. The agency record governs; check it and the company before acting.

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