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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.

Medical devices

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)

Food

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)

Food

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)

Drugs

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)

Medical devices

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)

Drugs

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)

Drugs

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)

Medical devices

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)

Medical devices

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)

Drugs

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)

Drugs

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)

Food

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)

Drugs

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)

Medical devices

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)

Drugs

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)

Medical devices

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)

Food

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)

Food

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)

Drugs

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)

Medical devices

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)

Drugs

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)

Drugs

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)

Medical devices

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)

Drugs

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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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.