FDA · Drug recall
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per… and 55 more products
- 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.