The Recall Desk

Archive

January 2017 recalls

913 recalls were announced in January 2017.

What the numbers show

Critical
104
Severe
443
High
205
Moderate
130
Low
31

Of the 913 recalls this month scored against our rubric, 11% are Critical, 49% are Severe.

601–700 of 913

  • SevereFDA (Drugs)·D-0347-2017·2017-01-11

    Wells Pharmacy Recalls Chorionic Gonadotropin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 1,753 kits of compounded Chorionic Gonadotropin injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2017·2017-01-11

    Wells Pharmacy Recalls Mitomycin Solution Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 122 syringes of Mitomycin Solution Injectable because the agency could not ensure the product was sterile.

    Product
    Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0365-2017·2017-01-11

    Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Methylcobalamin 1,000 mcg/mL Injectable vials because the agency could not ensure the product was sterile.

    Product
    Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2017·2017-01-11

    Wells Pharmacy Recalls Fluorescein/Indocyanine Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 203 kits of compounded Fluorescein/Indocyanine Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0250-2017·2017-01-11

    Tri-Coast Pharmacy Recalls B-Complex Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 67 vials of compounded B-Complex injections because the agency cannot assure the products are sterile.

    Product
    B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/ml). Compounded by Tri-Coast Pharmacy.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0407-2017·2017-01-11

    FDA Recalls Tri 1 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Tri 1 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.

    Product
    Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0288-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Acetate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Sermorelin Acetate 9 mg vials because there is a lack of assurance of sterility. The recall covers products compounded between May and November 2016.

    Product
    Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1161-2017·2017-01-11

    Tipiak Pearled Couscous Recalled for Potential Foreign Metal Fragments

    Tipiak Inc is recalling specific lots of Pearled Couscous due to the potential presence of foreign metal fragments.

    Product
    Tipiak Pearled Couscous Easy cooking 12.3 Oz (350g) Item Number: 10020450803 Product of France
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0947-2017·2017-01-11

    Aesculap Recalls Gomco Circumcision Clamps Due to Excessive Bleeding Reports

    Aesculap Implant Systems LLC is recalling 437 units of Gomco Circumcision Clamps nationwide after receiving complaints of excessive bleeding following use.

    Product
    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0269-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Lipo-C Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 69 vials of Lipo-C compounded between May and November 2016 because the agency could not ensure the products were sterile.

    Product
    Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1 mg/Thiamine HCL 50 mg/Rivoflavin-5-Phosphate Sod 5 mg/Niacinamide 50 mg/Dexpanthenol 5 mg/Pyridoxine HCL 1.25 mg/Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmac
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1168-2017·2017-01-11

    Elmec Caramel Bread Pudin Recalled for Undeclared Wheat and Soy Allergens

    Elmec Industries is recalling approximately 84,000 units of Caramel Bread Pudin sold in Puerto Rico due to undeclared wheat and soy allergens.

    Product
    Pudin es Cedo***Homestyle Caramel Bread Pudin***Ready to Eat***Hecho en Puerto Rico***Serving Size 3 oz (85g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0941-2017·2017-01-11

    Interventional Spine Recalls G3 Opticage Expandable Interbody Fusion Devices

    Interventional Spine Inc is recalling 239 G3 Opticage Expandable Interbody Fusion Devices because the proximal end may separate during implantation, preventing the device from expanding.

    Product
    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2017·2017-01-11

    Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association

    Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1167-2017·2017-01-11

    Elmec Industries Recalls 20 oz Pudding for Undeclared Wheat and Soy

    Elmec Industries is recalling 20 oz pudding containers in Puerto Rico due to undeclared wheat and soy allergens.

    Product
    Label reads in part as: "Ced¿ Pud¿n***Keep Refrigerated***NET WT 20 OZ (566 g)***Manufactured and Packed by Elmec Industries Inc.***229 Guanajibo Rd. Mayaguez, P.R. 00681".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0926-2017·2017-01-11

    Nurse Assist Recalls Normal Saline Flush Syringes Due to B. cepacia Contamination

    Nurse Assist, Inc. is recalling Normal Saline Flush syringes due to potential contamination with B. cepacia. The affected products were distributed in the US, US Virgin Islands, and Canada.

    Product
    Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17725·2017-01-11

    Linon Home Décor Recalls Cynthia Dressers Due to Tip-Over Hazard

    Linon Home Décor is recalling Cynthia dressers sold at Wayfair.com because they can tip over if not anchored, posing a risk of death or injury to children.

    Product
    Cynthia dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0372-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compound Due to Sterility Assurance Concerns

    Wells Pharmacy Network LLC is recalling 1,716 vials of a compounded injectable product nationwide due to a lack of assurance of sterility.

    Product
    MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 17 vials of TriMix injection because the agency could not ensure the products were sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2017·2017-01-11

    Smith & Nephew Recalls Modular SMF Hip Prostheses Due to Adverse Events

    Smith & Nephew is recalling Modular SMF and Modular REDAPT Hip Systems due to a higher-than-anticipated trend in complaints and adverse events.

    Product
    Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0332-2017·2017-01-11

    Wells Pharmacy Recalls MIC Combo Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling MIC Combo injectable vials because the agency could not ensure the product was sterile.

    Product
    MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0351-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits

    Wells Pharmacy Network LLC is recalling 908 compounded Chorionic Gonadotropin Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0278-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Nandrolone Decanoate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 701 vials of Nandrolone Decanoate 200 mg/ml because the agency could not ensure the products were sterile.

    Product
    Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0342-2017·2017-01-11

    Wells Pharmacy Recalls B-Complex Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling B-complex + Vit C injectable vials due to a lack of assurance of sterility.

    Product
    B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0264-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Infuvite IV Vials Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 161 vials of Infuvite IV compounded between May and November 2016 because the agency cannot assure the products are sterile.

    Product
    Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by Tri-Coast
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2017·2017-01-11

    Smith & Nephew Recalls Modular Hip Prosthesis Necks Due to Adverse Events

    Smith & Nephew is recalling 13,671 modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend.

    Product
    Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0350-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits

    Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin injectable kits due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2017·2017-01-11

    Smith & Nephew Recalls Modular REDAPT Hip Systems Due to Adverse Events

    Smith & Nephew is recalling 6,266 units of Modular REDAPT and Modular SMF Hip Systems worldwide due to a higher than anticipated complaint and adverse event trend.

    Product
    Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0382-2017·2017-01-11

    Wells Pharmacy Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 526 vials of compounded Nandrolone Decanoate injectable nationwide due to a lack of assurance of sterility.

    Product
    Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2017·2017-01-11

    Pride Mobility Recalls TRU-Balance 3 Power Positioning Systems

    Pride Mobility Products Corp is recalling 12,343 TRU-Balance 3 Power Positioning Systems because the back and tilt base can separate when tilted beyond the specified angle.

    Product
    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1143-2017·2017-01-11

    Derby City Vending Buffalo Chicken Sandwich Recalled for Undeclared Allergens

    Derby City Vending Inc. is recalling Buffalo Chicken Sandwiches because the labels failed to declare milk, egg, and soy.

    Product
    Derby City Vending Buffalo Chicken Sandwich Deli Selections Ingredients: Chicken***Ranch Cup; Pretzel bun***Lettuce, Tomato CONTAINS WHEAT Fresh Thru 12/4/16 Derby City Vending Louisville, KY 40206
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1176-2017·2017-01-11

    Eby-Brown Recalls Turkey and Cheese Sandwiches Due to Mold

    Eby-Brown is recalling specific lots of Turkey & Cheese Sandwiches because a customer reported the product was molding before the expiration date.

    Product
    TURKEY & CHEESE SANDWICH Net Wt 4,7 oz (133g) Savory turkey & cheese on wheat bread KEEP REFRIGERATED UPC 6 42984 67592 0
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0943-2017·2017-01-11

    MicroPort Orthopedics Recalls Profemur R Rasp Handles Due to Machining Issues

    MicroPort Orthopedics is recalling 20 units of Profemur R Rasp Handles because machining issues may prevent them from properly mating with broaches.

    Product
    PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0244-2017·2017-01-11

    Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations

    Apotex Corp. is voluntarily recalling Torsemide Tablets 20 mg due to CGMP deviations. The recall covers 35,819 bottles distributed in the United States.

    Product
    Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1172-2017·2017-01-11

    Eby-Brown Recalls Ham and Swiss Pretzel Subs Due to Mold

    Eby-Brown is recalling 1,422 Ham & Swiss Pretzel Subs because a customer reported the product was molding before its expiration date.

    Product
    HAM & SWISS PRETZEL SUB Net Wt 6.4 oz (181g) Thin sliced smoked ham piled high on a split top pretzel roll, topped with mild, nutty Swiss cheese KEEP REFRIGERATED UPC 6 42984 98519 7
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1170-2017·2017-01-11

    Eby-Brown Recalls Chicken and Cheese Subs Due to Mold

    Eby-Brown is recalling 741 Chicken and Cheese Subs because a customer reported the product was molding before its expiration date.

    Product
    CHICKEN AND CHEESE SUB Net Wt 6.4 oz (181g) Oven cooked chicken with American cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 98518 0
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0949-2017·2017-01-11

    Merit PreludeEASE Hydrophilic Sheath Introducer Dilator Recall

    Merit Medical Systems is recalling 335 PreludeEASE Hydrophilic Sheath Introducer Dilators because the tips are undersized and cannot pass a 0.021-inch guide wire.

    Product
    PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0245-2017·2017-01-11

    Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations

    Apotex Corp. is voluntarily recalling Torsemide Tablets, 5 mg, due to Current Good Manufacturing Practice (CGMP) deviations. The recall covers 13,179 bottles distributed in the United States.

    Product
    Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1174-2017·2017-01-11

    Eby Brown Recalls Smoked Ham and Cheese Subs Due to Mold

    Eby Brown is recalling 3,126 smoked ham and cheese subs after a customer reported mold before the expiration date. The product was distributed to 15 states.

    Product
    SMOKED HAM & CHEESE SUB Net Wt 5.9 oz (167g) Smoked ham with American cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67596 8
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1177-2017·2017-01-11

    Eby-Brown Recalls Turkey and Cheese Subs Due to Mold

    Eby-Brown is recalling 3,351 Turkey & Cheese Subs because a customer reported the product was molding before its expiration date.

    Product
    TURKEY & CHEESE SUB Net Wt 5.9 oz (167g) Oven roasted turkey with American cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67595 1
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1171-2017·2017-01-11

    Eby-Brown Recalls Chicken Salad Sandwiches Due to Mold

    Eby-Brown is recalling 4,712 chicken salad sandwiches because a customer reported the product was molding before its expiration date.

    Product
    CHICKEN SALAD SANDWICH Net Wt 4.5 oz (128g) Chunky chicken salad on wheat bread KEEP REFRIGERATED UPC 6 42984 67589 0
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1169-2017·2017-01-11

    Eby Brown Recalls American Classic Subs Due to Molding Before Expiration

    Eby Brown Co is recalling 3,268 American Classic Subs because a customer reported the product was molding before its expiration date.

    Product
    AMERICAN CLASSIC SUB Net Wt 6.5 oz (184g) Smoked ham, deli style bologna, hard salami with American and Swiss cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67594 4
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1175-2017·2017-01-11

    Eby-Brown Recalls Moldy Big Stack Sub Sandwiches

    Eby-Brown is recalling Big Stack Sub sandwiches after a customer reported the product was molding before its expiration date.

    Product
    THE BIG STACK SUB Net Wt 6.4 oz (181g) Roast beef, oven roasted turkey, smoked ham, hard salami with Swiss cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67593 7
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1173-2017·2017-01-11

    Eby Brown Recalls Italian Sub Sandwiches Due to Molding

    Eby Brown Co is recalling 4,171 Italian Sub sandwiches because a customer reported the product was molding before its expiration date.

    Product
    ITALIAN SUB Net Wt 5.5 oz (155g) Smoked ham, hard salami, pepperoni with provolone cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67597 5
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0243-2017·2017-01-11

    Gentell Hydrogel Wound Dressing Recalled for CGMP Deviations

    Gentell, Inc. is voluntarily recalling Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tubes due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1178-2017·2017-01-11

    Eby-Brown Recalls Tuna Salad Sandwiches Due to Molding

    Eby-Brown is recalling Tuna Salad Sandwiches after a customer reported the product was molding before its expiration date.

    Product
    TUNA SALAD SANDWICH Net Wt 4.5 oz (128g) Creamy tuna salad on wheat bread KEEP REFRIGERATED UPC 6 42984 67588 3
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1163-2017·2017-01-11

    Midwest International Longan Aril Recalled for Unsafe Food Additives

    Midwest International Corp is recalling Longan Aril because it contains unsafe food additives and undeclared colorants.

    Product
    LONGAN ARIL, Net Wt: 7.4oz (210g), contains yellow and orange labeling
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0856-2017·2017-01-11

    Mitsui Foods Recalls Fresh Catch Smoked Baby Clams Due to Seal Quality Issue

    Mitsui Foods Inc is recalling Fresh Catch Smoked Baby Clams because a packaging seal defect may allow the food to spoil and cause package swelling.

    Product
    Fresh Catch Smoked Baby Clams 3.53 oz. pouch (100g) Item Number 541187381, UPC 087381043895
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1181-2017·2017-01-11

    Market Pantry Peanut Butter Cookies Recalled for Incorrect Labeling

    Minnesota Best Maid Cookie Co. is recalling Market Pantry Peanut Butter Cookies because the containers have an incorrect bottom label.

    Product
    Market Pantry Peanut Butter Cookies. Net Wt. 10.8 oz (306g) UPC 92180 11707
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0242-2017·2017-01-11

    Gentell Hydrogel Ag Saturated Gauze Recalled for CGMP Deviations

    Gentell, Inc. is voluntarily recalling 3,000 units of Hydrogel Ag Saturated Gauze in three sizes due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0940-2017·2017-01-11

    Infraredx Recalls TVC Imaging System Due to Image Appearance Issues

    Infraredx, Inc. is recalling seven TVC Imaging System units because near-infrared images sometimes displayed lipid core plaques with an unusual horizontal orientation.

    Product
    TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infra
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0948-2017·2017-01-11

    Tepha GalaSHAPE 3D Medical Device Recalled for Endotoxin Specification Exceedance

    Tepha Incorporated is recalling 29 units of GalaSHAPE 3D medical devices because endotoxin levels slightly exceeded specifications.

    Product
    GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desire
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0326-2017·2017-01-11

    Qualitest Recalls Temazepam Capsules Due to Failed Stability Specifications

    Vintage Pharmaceuticals is recalling 1,200 bottles of Temazepam 7.5 mg capsules because they failed stability specifications. The affected lot is distributed nationwide.

    Product
    TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalNHTSA·17V029000·2017-01-10

    Honda and Acura Recall Vehicles for Front Passenger Air Bag Inflator Defect

    Honda is recalling specific Acura and Honda models because front passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    ACURA — ACURA, HONDA RL, ELEMENT, RIDGELINE, MDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·17V020000·2017-01-10

    BMW Recalls X5 and X6 Models for Air Bag Inflator Rupture Risk

    BMW is recalling 2007-2012 X5 and X6 vehicles because the front passenger air bag inflators may rupture during a crash, potentially causing serious injury or death.

    Product
    BMW — BMW X5, X6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V030000·2017-01-10

    Honda Recalls Vehicles for Front Passenger Air Bag Inflator Rupture Risk

    Honda is recalling specific 2006-2012 models because the front passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    HONDA — HONDA, ACURA ACCORD, CR-V, TSX, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V024000·2017-01-10

    Ford Recalls Vehicles for Air Bag Inflator Rupture Risk

    Ford is recalling specific 2005-2012 vehicles because passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    LINCOLN — LINCOLN, FORD, MERCURY MKZ, FUSION, GT, ZEPHYR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V015000·2017-01-10

    Land Rover Recalls Range Rovers for Air Bag Inflator Rupture Risk

    Jaguar Land Rover is recalling 2007-2012 Range Rovers because front passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V016000·2017-01-10

    Subaru and Saab Recall Vehicles Due to Air Bag Inflator Rupture Risk

    Subaru is recalling 2005-2008 models and 2006 Saab 9-2X vehicles because passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    SUBARU — SUBARU, SAAB BAJA, IMPREZA, 9-2X, TRIBECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V028000·2017-01-10

    Nissan Recalls Infiniti and Versa Models for Air Bag Inflator Rupture Risk

    Nissan is recalling specific Infiniti and Nissan Versa vehicles because the front passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    INFINITI — INFINITI, NISSAN FX35, FX45, M35, VERSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V017000·2017-01-10

    Mercedes-Benz Recalls Vehicles for Front Passenger Air Bag Inflator Rupture Risk

    Mercedes-Benz is recalling specific 2008-2012 models because front passenger air bag inflators may rupture during deployment, potentially sending metal fragments into the vehicle.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ C63, E350, C300, C350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V013000·2017-01-10

    Mazda Recalls B-Series Trucks Due to Air Bag Inflator Rupture Risk

    Mazda is recalling 2007-2009 B-Series trucks because the passenger air bag inflator may rupture in a crash, potentially causing serious injury or death.

    Product
    MAZDA — MAZDA B-SERIES TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·003-2017·2017-01-10

    Perfect Fit Meals Recalls Chicken Breast Due to Undeclared Allergens

    Perfect Fit Meals is recalling approximately 3,546 pounds of chicken breast product because it contains undeclared milk and wheat allergens.

    Product
    Perfect Fit Meals, LLC Recalls Chicken Breast Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·17065·2017-01-10

    Michaels Recalls Rock Salt Lamps Due to Shock and Fire Hazards

    Michaels is recalling about 80,000 Lumière brand rock salt lamps because the dimmer switch or outlet plug can overheat, posing shock and fire risks.

    Product
    Rock Salt Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V006000·2017-01-09

    Toyota Recalls Vehicles for Passenger Air Bag Inflator Rupture Risk

    Toyota is recalling specific 2006-2012 models because passenger air bag inflators may rupture in a crash, potentially sending metal fragments into the cabin.

    Product
    LEXUS — LEXUS, SCION, TOYOTA IS 250, ES350, XB, IS 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V005000·2017-01-09

    McLaren Recalls 2012 MP4-12C Spider for Air Bag Inflator Rupture Risk

    McLaren is recalling 2012 MP4-12C Spider vehicles because passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    MCLAREN — MCLAREN MP4-12C SPIDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·002-2017·2017-01-09

    Schreiber Recalls Chicken Tenders Due to Plastic Contamination and Misbranding

    Schreiber Processing Corp. is recalling approximately 2,330 pounds of chicken tenders that may contain plastic and are misbranded. The products were distributed in New Jersey, New York, and Washington.

    Product
    Schreiber Processing Corporation — Schreiber Processing Corp. Recalls Chicken Tender Products Due to Possible Foreign Matter Contamination and Misbranding
    Category
    Food
    Distribution
    3 states
  • ModerateNHTSA·17V008000·2017-01-09

    Heartland Recalls 2017 Mallard Trailers for Incorrect Certification Label

    Heartland is recalling 2017 Mallard recreational trailers because the certification label may contain incorrect tire size or pressure information, which could lead to improper tire inflation or overloading.

    Product
    HEARTLAND — HEARTLAND MALLARD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-010717·2017-01-07

    Chicken Strips May Be Contaminated with Listeria, USDA Says

    USDA FSIS issued a public health alert about ready-to-eat chicken breast strips produced by House of Raeford on Sept. 29, 2016 that may be contaminated with Listeria monocytogenes. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert For Chicken Strips Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V004000·2017-01-06

    Fisker Karma Recall: Passenger Air Bag Inflators May Rupture in Crash

    Karma Automotive is recalling 2012 Fisker Karma vehicles because passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    FISKER — FISKER KARMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-010617·2017-01-06

    USDA FSIS Public Health Alert: Sliced Deli Meat May Contain Listeria

    USDA FSIS issued a public health alert for sliced deli meat products produced by Peter DeFries Corporation between Dec. 14 and Dec. 29, 2016, due to possible Listeria monocytogenes contamination. The products were distributed to Dion's restaurant locations in Colorado, New Mexico, and Texas.

    Product
    FSIS Issues Public Health Alert For Sliced Deli Meat Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·17V007000·2017-01-06

    Kia Recalls One 2016 Optima for Driver Air Bag Defect

    Kia is recalling one 2016 Optima because the driver's frontal air bag inflator seal may not be installed properly, potentially reducing inflation in a crash.

    Product
    KIA — KIA OPTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·001-2017·2017-01-05

    4G Meat Processing Recalls Italian Sausage for Misbranding and Missing Labels

    4G Meat Processing LLC is recalling approximately 1,288 pounds of pork and turkey Caldarello Italian Sausage because the products contain undeclared MSG and lack required ingredients and safe handling statements on individual packages.

    Product
    4G Meat Processing LLC — Recall Notification Report 001-2017 (Italian Sausage)
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0949-2017·2017-01-04

    Marine AgriFuture Recalls Kahuko Sea Asparagus Due to Salmonella Illnesses

    Marine AgriFuture, LLC is recalling Kahuko Sea Asparagus because the product has been linked to Salmonella illnesses in Hawaii.

    Product
    Kahuko Sea Asparagus Packed in clear clamshell in 4 oz.. and 1 lb. weights and 5 lb. plastic bag. Keep refrigerated/. Rinse or blanch when ready to use. UPC 4 oz.: 897680001010; UPC 1 lb.: 897680001027; UPC 5 lb.: 897680001041. Marine Agrifuture, LLC 56-1081 Kameha
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0948-2017·2017-01-04

    Marine AgriFuture Recalls Robusto Ogo Linked to Salmonella Illnesses

    Marine AgriFuture is recalling 1,098 lbs of Robusto Ogo seaweed distributed in Hawaii, California, Washington, and Japan due to a link to Salmonella illnesses in Hawaii.

    Product
    Robusto Ogo Stored at 70F: Packed in plastic bags in varying weights from 0.5 lb. to 35 lb. No codes on product. Marine Agrifuture, LLC 56-1081 Kamehameha Hwy Kahuku, HI 96731
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0947-2017·2017-01-04

    Marine AgriFuture Recalls Kahuko Ogo Linked to Salmonella Illnesses

    Marine AgriFuture is recalling Kahuko Ogo harvested from their farm because it has been linked to Salmonella illnesses in Hawaii.

    Product
    Kahuko Ogo Stored at 40F: Packed in plastic bags in varying weights from 0.5 lb. to 35 lb. No codes on product. Marine Agrifuture, LLC 56-1081 Kamehameha Hwy Kahuku, HI 96731
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1046-2017·2017-01-04

    Sunset Natural Products Recalls Goji Dietary Supplements Under Consent Decree

    Sunset Natural Products Inc. is recalling Goji Dietary Supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.

    Product
    Goji Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1069-2017·2017-01-04

    Sunset Natural Products Recalls Colon Cleanser Dietary Supplement

    Sunset Natural Products Inc. is recalling Colon Cleanser Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Colon Cleanser Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0963-2017·2017-01-04

    Sunset Natural Products Recalls Colageina Orange Dietary Supplement Jars

    Sunset Natural Products Inc. is recalling Colageina Orange dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Colageina Orange, (195 g per Jar)
    Category
    Food
    Distribution
    2 states

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