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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 Jul 8, 2015

Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus…

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

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA (openFDA device enforcement)

Medical devices

Reported Jul 8, 2015

Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and…

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

Spine Wave, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Jul 8, 2015

OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA…

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

The Harvard Drug Group, LLC

FDA (openFDA drug enforcement)

Drugs

Reported Jul 1, 2015

Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2…

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

Indiana Botanic Gardens, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Jun 24, 2015

T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx…

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

MRP, LLC dba AMUSA

FDA (openFDA device enforcement)

Drugs

Reported Jun 24, 2015

Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating…

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

Ohm Laboratories, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jun 17, 2015

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only,…

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

Baxter Healthcare Corp.

FDA (openFDA drug enforcement)

Medical devices

Reported Jun 17, 2015

ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only…

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

Orthofix, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Jun 3, 2015

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories,…

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

Boehringer Ingelheim Roxane Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Jun 3, 2015

Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are…

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

Volk Optical Inc.

FDA (openFDA device enforcement)

Meat & poultry

Reported May 22, 2015

Culinary Brands Inc. Recalls Pork Products Due to Misbranding and Undeclared Allergen

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

Ruiz Food Products, Inc.

USDA FSIS

Drugs

Reported May 20, 2015

Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC…

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

Apotex Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 20, 2015

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045,…

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

Hospira Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 20, 2015

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7…

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

Janssen Pharmaceuticals, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported May 6, 2015

4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe…

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

Alphatec Spine, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 6, 2015

Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast…

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

Coloplast Manufacturing US, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Apr 29, 2015

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and…

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

Catheter Research, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Apr 22, 2015

Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054,…

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

Actavis Laboratories

FDA (openFDA drug enforcement)

Drugs

Reported Apr 15, 2015

MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia.…

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

Hospira Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Food

Reported Apr 15, 2015

Nutri-Dyn, 5-HTP Extra Strength, Pharmaceutical Grade from Switzerland, Dietary Supplement 60 capsules in plastic…

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

Nutri-Dyn Midwest, Inc.

FDA (openFDA food enforcement)

Medical devices

Reported Apr 8, 2015

Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway…

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

King Systems Corp.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 1, 2015

NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage:…

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

Zimmer Trabecular Metal Technology, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 25, 2015

LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the…

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

LeMaitre Vascular, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Mar 11, 2015

Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma…

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

Actavis Inc.

1 more product in this recall

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.