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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.

983 stored notices, reported between Jun 20, 2012 and Nov 11, 2026. Newest first.

Medical devices

Reported Apr 30, 2014

ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Ev3, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Apr 30, 2014

Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a.…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

9 more products in this recall

FDA (openFDA drug enforcement)

Food

Reported Apr 23, 2014

"Honey Roasted Peanuts Golden Roast" sold under the Fisher brand and packaged in 14 oz. plastic jars.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

John B. Sanfilippo & Son Inc.

FDA (openFDA food enforcement)

Drugs

Reported Apr 2, 2014

DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Hill Dermaceuticals, Inc.

8 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Apr 2, 2014

Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Spacelabs Healthcare, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Mar 26, 2014

Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Mar 26, 2014

Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Pfizer US Pharmaceutical Group

FDA (openFDA drug enforcement)

Food

Reported Mar 19, 2014

MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

C. H. Guenther & Sons, Inc.

FDA (openFDA food enforcement)

Food

Reported Mar 19, 2014

Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case. Keep Refrigerated Distributed by…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

F & S Produce Co., Inc.

FDA (openFDA food enforcement)

Food

Reported Mar 19, 2014

STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Raymond-Hadley Corp.

FDA (openFDA food enforcement)

Medical devices

Reported Mar 12, 2014

FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Djo Surgical

FDA (openFDA device enforcement)

Drugs

Reported Mar 12, 2014

Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Fresenius Kabi USA, LLC

FDA (openFDA drug enforcement)

Medical devices

Reported Mar 12, 2014

BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Heraeus Kulzer, LLC.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 12, 2014

Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mako Surgical Corporation

FDA (openFDA device enforcement)

Drugs

Reported Mar 5, 2014

Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Actavis Elizabeth LLC

FDA (openFDA drug enforcement)

Drugs

Reported Mar 5, 2014

Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Actavis

FDA (openFDA drug enforcement)

Medical devices

Reported Mar 5, 2014

NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

NxStage Medical, Inc.

FDA (openFDA device enforcement)

Food

Reported Mar 5, 2014

Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Unified Grocers Inc.

FDA (openFDA food enforcement)

Drugs

Reported Feb 19, 2014

Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mylan Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jan 29, 2014

ISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781155601.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Aidapak Services, LLC

264 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 8, 2014

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Sandoz Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Jan 1, 2014

Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Edwards Lifesciences, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Dec 25, 2013

outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Dec 18, 2013

Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Boehringer Ingelheim Roxane 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.