Category
Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIBackache & 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIMulti-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IICold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IILite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIMulti 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IICetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIBack Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIMidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIDologen (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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIEphedrine 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIDBI 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IICystex 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IILegatrin 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIExtra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IICHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIMaximum 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IIAERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IICold 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
cGMP deviations
- 2022-02-09FDA-DrugUltra Seal CorporationClass IINasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
cGMP deviations
- 2022-02-09FDA-DrugIdeal Specialty Apothecary, Inc. dba Ideal PharmacyClass IIMedroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
Lack of Assurance of Sterility
- 2022-02-09FDA-DrugTeva Pharmaceuticals USAClass IIDoxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
- 2022-02-02FDA-DrugDental Alliance Holdings LLCClass IIICTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- 2022-02-02FDA-DrugDental Alliance Holdings LLCClass IIICariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- 2022-02-02FDA-DrugDental Alliance Holdings LLCClass IIICTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- 2022-02-02FDA-DrugDental Alliance Holdings LLCClass IIICTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- 2022-02-02FDA-DrugDental Alliance Holdings LLCClass IIICTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- 2022-02-02FDA-DrugDental Alliance Holdings LLCClass IIICTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- 2022-02-02FDA-DrugDental Alliance Holdings LLCClass IIICariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- 2022-02-02FDA-DrugMylan Pharmaceuticals IncClass IIProctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.
cGMP deficiencies
- 2022-02-02FDA-DrugAmerican Health PackagingClass IIMetoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
Failed Dissolution Specifications
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