Labeling and dosing error recalls
Nothing is contaminated in these recalls — the package says the wrong thing. That can mean a bottle holding a different strength than the label states, two products packed in the wrong carton, or missing directions. For medication these can matter as much as contamination, because the dose taken is the wrong one.
972 stored notices, reported between Jun 20, 2012 and Sep 23, 2026. Newest first.
Reported Jul 17, 2013
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Bryan Medical Inc.
FDA (openFDA device enforcement)
Reported Jul 10, 2013
Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cheryls
FDA (openFDA food enforcement)
Reported Jul 3, 2013
Enzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Enzyme Formulations, Inc.
FDA (openFDA food enforcement)
Reported Jul 3, 2013
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hill Dermaceuticals, Inc.
FDA (openFDA drug enforcement)
Reported Jul 3, 2013
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc. Cardiac Rhythm Disease Management
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2013
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hi-Tech Pharmacal Co., Inc.
FDA (openFDA drug enforcement)
Reported Jun 26, 2013
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Mission Pharmacal Co.
FDA (openFDA drug enforcement)
Reported Jun 12, 2013
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
FDA (openFDA device enforcement)
Reported May 29, 2013
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
FDA (openFDA device enforcement)
Reported May 29, 2013
Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.King Legacy, a wholly owned subsidiary
10 more products in this recall
FDA (openFDA drug enforcement)
Reported May 22, 2013
BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hi-Tech Pharmacal Co., Inc.
FDA (openFDA drug enforcement)
Reported May 22, 2013
Island Mix, 12 oz. with best by date of 02/17/2014
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nuts Are Good! Inc.
FDA (openFDA food enforcement)
Reported May 8, 2013
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hi-Tech Pharmacal Co., Inc.
FDA (openFDA drug enforcement)
Reported May 8, 2013
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NxStage Medical, Inc.
FDA (openFDA device enforcement)
Reported May 8, 2013
Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Reckitt Benckiser Inc.
FDA (openFDA drug enforcement)
Reported Apr 24, 2013
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synvasive Technology Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2013
Giant Eagle Lotsa Chocolate Chip Cookies
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Giant Eagle
FDA (openFDA food enforcement)
Reported Apr 17, 2013
Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mike-Sells Potato Chip Co.
FDA (openFDA food enforcement)
Reported Apr 10, 2013
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.West-ward Pharmaceutical Corp.
FDA (openFDA drug enforcement)
Reported Apr 3, 2013
Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cooper Surgical, Inc.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2013
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Hill Dermaceuticals, Inc.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 3, 2013
PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.L. Perrigo Co.
FDA (openFDA drug enforcement)
Reported Mar 27, 2013
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Keystone Dental Inc.
FDA (openFDA device enforcement)
Reported Mar 27, 2013
Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physicians Total Care, Inc.
FDA (openFDA drug enforcement)
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