The Recall Desk

Archive

November 2017 recalls

629 recalls were announced in November 2017.

What the numbers show

Critical
72
Severe
168
High
284
Moderate
80
Low
25

Of the 629 recalls this month scored against our rubric, 11% are Critical, 27% are Severe.

601–629 of 629

  • HighNHTSA·17V690000·2017-11-01

    Heartland Recalls 2018 Pioneer Trailers Due to Propane Leak Risk

    Heartland is recalling 2018 Pioneer recreational trailers because the propane manifold block may be mounted too close to the shackle, creating a leak risk.

    Product
    HEARTLAND — HEARTLAND PIONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V691000·2017-11-01

    Nissan Recalls 2017-2018 Infiniti QX30 for Air Bag Deployment Risk

    Nissan is recalling 2017-2018 Infiniti QX30 vehicles because the driver's air bag may deploy unexpectedly due to steering component grounding issues.

    Product
    INFINITI — INFINITI QX30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0046-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Infusion Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 1,152 bags of compounded Oxytocin 40 units in Lactated Ringer's USP because the drug was subpotent.

    Product
    Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0034-2018·2017-11-01

    Chun Yuen Trading Recalls Instant Reishi Coffee for Undeclared Milk

    Chun Yuen Trading Co., Inc. is recalling Instant Reishi Coffee, 4 in 1 because milk is not declared on the product labeling.

    Product
    Instant Reishi Coffee, 4 in 1; Ca Phe Ling Chi; 20 sachets, Net Wt. 360g (12.7 oz.) UPC 8 93663 00225 8 Ingredients: Sugar, Non Dairy Creamer, Instant Coffee, Reishi Extract. Chun Yuen Trading, So. El Monte, CA
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0040-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Lactated Ringer's Injection Bags

    Pharmedium Services, LLC is voluntarily recalling 978 bags of compounded Oxytocin in Lactated Ringer's Injection because the drug was subpotent.

    Product
    Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2018·2017-11-01

    GORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk

    W.L. Gore & Associates is recalling 12,197 GORE TAG Thoracic Endoprosthesis units worldwide due to a risk of incomplete or partial deployment during endovascular procedures.

    Product
    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0033-2018·2017-11-01

    Enlightened Pina Colada Ice Cream Recalled for Undeclared Coconut

    Beyond Better Foods is recalling Enlightened Pina Colada Ice Cream because it contains undeclared coconut, a major food allergen.

    Product
    ENLIGHTENED THE GOOD-FOR-YOU ICE CREAM 60 CALORIES PER SERVING PINA COLADA MORE PROTEIN. LESS SUGAR 1 PINT LOW FAT ICE CREAM, UPC 8 52109 33108 6. KEEP FROZEN.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0032-2018·2017-11-01

    Kenny's Buckeye Pie Recalled for Undeclared Wheat

    Kenny's Great Pies, Inc. is recalling Buckeye Pies in Ohio due to undeclared wheat, a common allergen.

    Product
    Kenny's Buckeye Pie, Net Wt.22 oz. (624g).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0049-2018·2017-11-01

    FDA Requests Removal of Ablatherm Ultrasound System Software Settings

    FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.

    Product
    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-0039-2018·2017-11-01

    Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

    Pharmedium Services, LLC is voluntarily recalling 390 bags of compounded Oxytocin 20 units in Lactated Ringer's Injection due to subpotent drug levels.

    Product
    Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0044-2018·2017-11-01

    Bard Max-Core Biopsy Instruments Recalled for Malfunction

    Bard Peripheral Vascular Inc is recalling 110,550 Max-Core Disposable Core Biopsy Instruments due to increased complaints of failure to prime, fire, or obtain samples.

    Product
    BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0050-2018·2017-11-01

    Nucletron Oncentra Brachy 4.5 Software Recalled for Incorrect Source Step Size

    Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.

    Product
    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0053-2018·2017-11-01

    Aidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg tablets distributed in Florida due to out-of-specification impurities.

    Product
    ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0030-2018·2017-11-01

    Diet Rite Pure Zero Cola Recalled for Caffeine Mislabeling

    Dr. Pepper Snapple Group is recalling Diet Rite Pure Zero Cola because the product is labeled as caffeine-free but contains caffeine.

    Product
    Diet Rite, Pure Zero Cola, 0 calories, 0 caffeine, 0 sodium, Bottled under the authority of Dr. Pepper/Seven up Inc. Plano TX. packed in 2 liter bottles, 0.5 liter bottles, and 12 oz cans.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0047-2018·2017-11-01

    Siemens Medical Solutions Recalls Torque Wrenches for Symbia CT Devices

    Siemens Medical Solutions is recalling 16 torque wrenches used to install Symbia CT scanners because the tools were found to be out of tolerance.

    Product
    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0029-2018·2017-11-01

    Becton Dickinson Recalls ChloraPrep Applicators Due to Labeling Error

    Becton Dickinson is recalling 628,000 ChloraPrep OneStep applicators because the immediate package is incorrectly labeled as Clear instead of Hi Lite Orange.

    Product
    ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0046-2018·2017-11-01

    Beckman Coulter Recalls Power Processor 1K Stockyard Due to Software Error

    Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.

    Product
    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0031-2018·2017-11-01

    Pacific Foods Recalls Organic Tomato Soup Due to Under-Processing

    Pacific Foods of Oregon is recalling specific lots of organic tomato and roasted red pepper soup due to potential under-processing.

    Product
    SKU 57879, Trader Joe's Organic Tomato & Roasted Red Pepper Soup, packaged in a Tetra Pak aseptic container/carton. There are 12 cartons per case. Net Wt. 32 fl. oz. UPC 00578790. Item # 52603-05405, Pacific Organic Roasted Red Pepper and Tomato Soup Canadian, packaged in
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0042-2018·2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 46 EMPOWR PS Knee Inserts because one unit was packaged with the wrong implant. The recall covers US nationwide distribution.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2018·2017-11-01

    Sysmex Fluorocell PLT Reagent Recalled for Potential Inaccurate Platelet Results

    Sysmex America is recalling Fluorocell PLT reagent lots because they may produce falsely low platelet results, potentially affecting diagnostic accuracy.

    Product
    Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2018·2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0051-2018·2017-11-01

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt USA is recalling 5mg Enalapril Maleate tablets because they failed impurity specifications. The recall covers 5,050 bottles distributed nationwide.

    Product
    Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0033-2018·2017-11-01

    AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse

    AbbVie is recalling specific lots of AndroGel testosterone gel because prolonged exposure to temperatures outside labeled storage conditions may have affected the product.

    Product
    AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0073-2018·2017-11-01

    Vi-Jon Recalls Equate and Studio 35 Face Moisturizers for Stability Failures

    Vi-Jon, Inc. is recalling Equate and Studio 35 Clarifying Face Daily Moisturizers because the products failed stability specifications. The recall covers 67,532 bottles distributed nationwide.

    Product
    Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmo
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0034-2018·2017-11-01

    AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse

    AbbVie is recalling 48 cartons of AndroGel testosterone gel distributed in Arizona due to prolonged exposure to temperatures outside labeled storage conditions.

    Product
    AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0146-2018·2017-11-01

    Taro Recalls Fluocinonide Gel Due to Dapsone Cross-Contamination

    Taro Pharmaceuticals is recalling 16,944 tubes of Fluocinonide Gel USP 0.05% because traces of Dapsone were found in the finished product.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0052-2018·2017-11-01

    Teva Recalls Methylphenidate Hydrochloride Tablets Due to Dissolution Failures

    Teva Pharmaceuticals USA is recalling 58,292 bottles of Methylphenidate Hydrochloride Tablets USP, 20 mg, because they failed to meet dissolution specifications.

    Product
    Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
    Category
    Drug
    Distribution
    Distributed nationwide

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