The Recall Desk

Archive

August 2014 recalls

458 recalls were announced in August 2014.

What the numbers show

Critical
18
Severe
98
High
154
Moderate
168
Low
20

Of the 458 recalls this month scored against our rubric, 4% are Critical, 21% are Severe.

Which agencies issued them

401–458 of 458

  • ModerateFDA (Drugs)·D-1489-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Baby's Relief Creams

    Dermamedics, L.L.C. is recalling specific lots of Dermamedics and Therametics Baby's Relief Calm and Repair Cream because the products are unapproved new drugs and misbranded.

    Product
    Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1493-2014·2014-08-06

    Dermamedics Calm and Correct Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Calm and Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2286-2014·2014-08-06

    GM Manufacturing Recalls Albert Capsules for cGMP Violations

    GM Manufacturing is recalling Albert Capsules dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Albert, Capsules
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2251-2014·2014-08-06

    GM Manufacturing Recalls Platinum B Blister Packs for cGMP Violations

    GM Manufacturing is recalling 5,000 units of Platinum B dietary supplements in California due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Platinum B, Blister Packs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2283-2014·2014-08-06

    GM Manufacturing Recalls Tendon & Muscle Plus Dietary Supplements

    GM Manufacturing is recalling Tendon & Muscle Plus dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Tendon & Muscle Plus, Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2270-2014·2014-08-06

    GM Manufacturing Recalls Maxium and Prolong Dietary Supplements

    GM Manufacturing is recalling Maxium and Prolong capsules due to significant violations of dietary supplement manufacturing regulations.

    Product
    Maxium, Capsules; Prolong, Capsules
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2119-2014·2014-08-06

    Teleflex Medical Recalls Emerald Fiberoptic Blades Due to Packaging Error

    Teleflex Medical is recalling 120 units of Emerald Fiberoptic Blades because the boxes contained incorrect Miller 4 blades instead of the labeled Macintosh 4 blades.

    Product
    Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-2278-2014·2014-08-06

    GM Manufacturing Recalls Detoxification Plus Dietary Supplements

    GM Manufacturing is recalling Detoxification Plus dietary supplements due to significant violations of current good manufacturing practice (cGMP) regulations.

    Product
    Detoxification Plus, Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1494-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions

    Dermamedics, L.L.C. is recalling specific Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2249-2014·2014-08-06

    GM Manufacturing Recalls Affirm XL Blister Packs for cGMP Violations

    GM Manufacturing is recalling 4,000 units of Affirm XL dietary supplements in California due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Affirm XL, Blister Packs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2271-2014·2014-08-06

    GM Manufacturing Recalls Serrapeptase Bottles for cGMP Violations

    GM Manufacturing is recalling Serrapeptase, 100cc HDPE Bottles due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

    Product
    Serrapeptase, 100cc HDPE Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1488-2014·2014-08-06

    Dermamedics Calm & Correct Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Calm & Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2125-2014·2014-08-06

    DeRoyal Cardiac Hypothermia Tray Recalled Due to Contaminated Irrigation Sets

    DeRoyal is recalling Cardiac Hypothermia Trays because they contained irrigation sets previously recalled by Hospira.

    Product
    DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2228-2014·2014-08-06

    Purefruit Chile Recalls Market Pantry Applesauce Pouches Due to Mold Risk

    Purefruit Chile S.A. is recalling Market Pantry applesauce pouches due to the possibility of mold. The product was distributed nationwide.

    Product
    Market Pantry Apple; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***market pantry Apple Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2269-2014·2014-08-06

    GM Manufacturing Recalls Actra-SX Vinyl Bags for cGMP Violations

    GM Manufacturing is recalling 188 units of Actra-SX Vinyl Bags distributed in California due to significant violations of dietary supplement cGMP regulations.

    Product
    Actra-SX, Vinyl Bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2246-2014·2014-08-06

    GM Manufacturing Recalls Oyavon Blister Packs for cGMP Violations

    GM Manufacturing is recalling 3,404 units of Oyavon dietary supplements distributed in California due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Oyavon, Blister Packs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1504-2014·2014-08-06

    Daiichi Sankyo Recalls Tribenzor Tablets Due to Temperature Abuse

    Daiichi Sankyo is recalling specific lots of Tribenzor tablets because they were not stored at controlled room temperature during shipping.

    Product
    Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2232-2014·2014-08-06

    Purefruit Chile Recalls HyVee Applesauce Pouches Due to Mold Risk

    Purefruit Chile S.A. is recalling specific HyVee applesauce pouches due to the possibility of mold. Consumers should check their pantry for the affected product.

    Product
    HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, "***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2287-2014·2014-08-06

    GM Manufacturing Recalls CKLS Capsules for cGMP Violations

    GM Manufacturing is recalling CKLS capsules due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

    Product
    CKLS, Capsules
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2259-2014·2014-08-06

    GM Manufacturing Recalls Bitter Melon Supplements for cGMP Violations

    GM Manufacturing is recalling 380 units of Bitter Melon dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Bitter Melon, 225cc HDPE Bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2280-2014·2014-08-06

    GM Manufacturing Recalls Stomach & Spleen Plus Dietary Supplements

    GM Manufacturing is recalling Stomach & Spleen Plus dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Stomach & Spleen Plus, Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1501-2014·2014-08-06

    Daiichi Sankyo Recalls Azor Tablets Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 5 bottles of Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg/40 mg because they were not stored at controlled room temperature during shipping.

    Product
    Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2014·2014-08-06

    Nidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label

    Nidek Inc. is recalling 29 MC-500 Multicolor Laser Photocoagulators because the laser aperture label was not affixed to the devices prior to shipment.

    Product
    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2281-2014·2014-08-06

    GM Manufacturing Recalls Bone & Joint Plus Dietary Supplements

    GM Manufacturing is recalling Bone & Joint Plus dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Bone & Joint Plus, Bottles
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1507-2014·2014-08-06

    Benicar HCT Tablets Recalled Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 86 bottles of Benicar HCT 40 mg/12.5 mg because they were not stored at controlled room temperature during shipping.

    Product
    Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2134-2014·2014-08-06

    Brainlab Patient Data Manager 2.0 Software Recall for Image Display Defects

    Brainlab AG is recalling Patient Data Manager 2.0 software due to defects in transferring and displaying non-square pixel medical images.

    Product
    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2230-2014·2014-08-06

    Purefruit Chile Recalls Pouched Applesauce Due to Potential Mold

    Purefruit Chile S.A. is recalling fruty U applesauce pouches due to the possibility of mold. The product was distributed to retail stores nationwide.

    Product
    fruty U applesauce, apple; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***fruty U APPLE applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of…
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1486-2014·2014-08-06

    Oxycodone Hydrochloride Oral Solution Recalled for Stability Failure

    Boehringer Ingelheim Roxane Inc is recalling 2,149 vials of Oxycodone Hydrochloride Oral Solution due to out-of-specification preservative levels.

    Product
    OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1485-2014·2014-08-06

    Pfizer Recalls Cardura XL Tablets Due to Degradation Specifications

    Pfizer is recalling 22,461 bottles of Cardura XL 4 mg tablets because the product may not meet specifications for a product degradant.

    Product
    Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2127-2014·2014-08-06

    Small Bone Innovations Recalls AutoFIX Cannulated Compression Screw Systems for IFU Update

    Small Bone Innovations is recalling 506 units of 3.0/4.0mm AutoFIX Cannulated Compression Screw Systems to update the Instructions for Use (IFU).

    Product
    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2129-2014·2014-08-06

    Septodont Recalls Compolite Bond SE Due to Incorrect Packaging

    Septodont is recalling 24 units of Compolite Bond SE dental adhesive because the material was incorrectly packaged. The product was distributed to wholesalers in Pennsylvania and New York.

    Product
    Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2133-2014·2014-08-06

    Siemens Dimension Integrated Chemistry Systems Recalled for Photometer Misassembly

    Siemens is recalling 15 Dimension Integrated Chemistry Systems due to a photometer misassembly issue that may shorten the life of the source lamp.

    Product
    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2128-2014·2014-08-06

    Septodont Recalls Self-Etch Bond Adhesive Due to Packaging Error

    Septodont is recalling Self-Etch bond adhesive because the material was incorrectly packaged. The recall involves 60 units distributed to two wholesalers in Pennsylvania and New York.

    Product
    Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
    Category
    Medical Device
    Distribution
    2 states
  • HighCPSC·14250·2014-08-05

    Samson International Recalls Spencer Bar Stool Due to Fall Hazard

    Samson International is recalling Spencer Bar Stools sold at Costco because the footrest can crack, posing a fall hazard. No injuries have been reported.

    Product
    Spencer Bar Stool
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14249·2014-08-05

    Scubapro Aladin2 Dive Computers Recalled for Decompression Sickness Risk

    Johnson Outdoors Diving is recalling Scubapro Aladin2 dive computers because they may leak and stop working, posing a risk of injury from decompression sickness.

    Product
    Scubapro Aladin2 dive computers, commonly referred to as Aladin Square dive computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V476000·2014-08-04

    Grand Design Recalls 2014 Momentum Trailers Due to Suspension Bolt Defect

    Grand Design is recalling 2014 Momentum 355th, 380th, and 385th fifth wheel trailers because suspension bolts may shear, potentially causing a crash.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM 355TH, MOMENTUM 380TH, MOMENTUM 385TH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V475000·2014-08-04

    Toyota Recalls FJ Cruiser and Tacoma for Incorrect Tire Placard Information

    Toyota is recalling 2008-2014 FJ Cruiser and Tacoma vehicles with specific accessory wheels because the tire placard may list incorrect spare tire size or inflation pressure.

    Product
    TOYOTA — TOYOTA FJ CRUISER, TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V473000·2014-08-01

    Nova Bus Recalls 2013 LFS Transit Buses for Wiper Linkage Bolt Issue

    Nova Bus is recalling 189 model year 2013 LFS transit buses because a windshield wiper linkage bolt may loosen, potentially rendering wipers inoperable and increasing crash risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide

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