The Recall Desk

Archive

February 2016 recalls

511 recalls were announced in February 2016.

What the numbers show

Critical
28
Severe
159
High
175
Moderate
135
Low
14

Of the 511 recalls this month scored against our rubric, 5% are Critical, 31% are Severe.

401–500 of 511

  • HighNHTSA·16E011000·2016-02-09

    Haier Recalls 55-Inch LED Televisions in Fifth-Wheel Recreational Vehicles

    Haier is recalling 55-inch LED televisions installed in fifth-wheel recreational vehicles because mounting brackets may separate, causing the TVs to fall.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·015-2016·2016-02-09

    Hormel Recalls Dinty Moore Beef Stew Due To Foreign Matter

    Hormel Foods is recalling approximately 450 pounds of Dinty Moore Beef Stew cans due to possible contamination with flashlight parts. No illnesses have been reported.

    Product
    Hormel Foods Corporation — Hormel Foods Corporation Recalls Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • CriticalUSDA FSIS·014-2016·2016-02-08

    Vosges Recalls Uncured Bacon Ganache Chocolate Bars for Undeclared Coconut

    Vosges, LTD is recalling 135 pounds of Uncured Bacon Ganache chocolate bars sold at Trader Joe's in four states because the product contains undeclared coconut, a known allergen.

    Product
    La Montagne Holdings LLC — Vosges, LTD Recalls Uncured Bacon Ganache Chocolate Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·16V071000·2016-02-05

    BMW Recalls Vehicles Due to Driver Air Bag Inflator Rupture Risk

    BMW is recalling approximately 840,000 vehicles because the driver's frontal air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    BMW — BMW 128I, X6 SAC, X5 SAV, 135I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V069000·2016-02-05

    GM Recalls 2015-2016 Trucks and SUVs for Brake Pedal Defect

    General Motors is recalling specific 2015-2016 Chevrolet and GMC trucks and SUVs because the brake pedal pivot nut may loosen, potentially making the brake pedal inoperative.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 2500, SIERRA 3500, SILVERADO 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·013-2016·2016-02-05

    Marin Pasta Works Recalls Pork Ravioli Produced Without Federal Inspection

    Marin Pasta Works is recalling 491 pounds of pork ravioli produced without federal inspection. The products were distributed to retail locations in California.

    Product
    Marin Pasta Works Recalls Pork Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V066000·2016-02-05

    Peterbilt Recalls 2015-2016 Trucks Due to Drive Axle Nut Defect

    PACCAR is recalling 2015-2016 Peterbilt 365 and 367 trucks because improperly tightened drive axle nuts may cause the driveshaft to disconnect, increasing crash risk.

    Product
    PETERBILT — PETERBILT 367, 365
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V065000·2016-02-05

    Toyota and Lexus Vehicles Recalled for Side Air Bag Defect

    Toyota is recalling specific 2003-2006 Land Cruiser, LX470, Tundra, Sequoia, 4Runner, and GX470 vehicles because side air bags may deploy unexpectedly, increasing injury risk.

    Product
    LEXUS — LEXUS, TOYOTA LX470, GX470, 4RUNNER, LAND CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V070000·2016-02-05

    Kia Recalls 2011 Fortes for Transmission Fluid Leak Risk

    Kia is recalling 2011 Fortes because a defective transmission cooler hose may leak fluid, potentially causing the vehicle to stop moving and increasing crash risk.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E009000·2016-02-04

    Takata Recalls Side Air Bag Inflators Due to Rupture Risk

    Takata is recalling specific side air bag inflators manufactured in December 2014 because a manufacturing error could cause them to rupture and propel metal fragments into the vehicle.

    Product
    AIR BAGS:SIDE/WINDOW recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16096·2016-02-04

    CE North America Recalls KUL Fan Heaters Due to Fire Hazard

    CE North America is recalling KUL portable fan heaters sold at Bed Bath & Beyond because they can overheat and catch fire. Four fire incidents have been reported, with no injuries.

    Product
    KUL Fan Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16095·2016-02-04

    Wedgwood Decorative Baby Rattles Recalled Due to Choking Hazard

    WWRD is recalling Wedgwood Peter Rabbit decorative baby rattles because ball bearings can release, posing a choking hazard to young children.

    Product
    Wedgwood Peter Rabbit decorative baby rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E010000·2016-02-04

    Helmet City Recalls Model 115 Helmets Due to Strap Stretching

    Helmet City, Inc. is recalling 270 Model 115 German helmets, size XL, because the straps may stretch excessively during a crash, failing to keep the helmet secured.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0627-2016·2016-02-03

    Sentara Recalls Ascorbic Acid Syringes Due to Sterility Concerns

    Sentara Enterprises is recalling 7 syringes of Ascorbic Acid 500mg because the product's sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0629-2016·2016-02-03

    Sentara Recalls Cefepime Homepumps Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of Cefepime Homepumps because the sterility of the product cannot be guaranteed.

    Product
    CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0626-2016·2016-02-03

    Sentara Recalls Ganciclovir Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Ganciclovir in NS Homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.

    Product
    GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0689-2016·2016-02-03

    Cook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems

    Cook Medical is recalling 753 Zilver 518RX Vascular Stent delivery systems because a manufacturing defect may cause the catheter joint to separate during use.

    Product
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0633-2016·2016-02-03

    Sentara Recalls Fluconzole Bags Due to Sterility Assurance Issues

    Sentara Enterprises is recalling 7 bags of Fluconzole in NaCl 400mg because product sterility cannot be guaranteed. The affected lots were distributed in Virginia and North Carolina.

    Product
    FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·16090·2016-02-03

    Rockwood Multi-Function Power Packs Recalled Due to Fire Hazard

    Eastwood is recalling Rockwood power packs because their lithium-ion batteries can burst during charging, posing a fire hazard.

    Product
    Rockwood Multi-function power packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0631-2016·2016-02-03

    Sentara Recalls Morphine Infusion Bags Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Morphine 10mg/ml in NS infusion bags because the sterility of the product cannot be guaranteed.

    Product
    MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0635-2016·2016-02-03

    Sentara Recalls Nafcillin Bags Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling 28 bags of Nafcillin 2GM in NS due to a lack of assurance of sterility. The affected product was distributed in Virginia and North Carolina.

    Product
    Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0642-2016·2016-02-03

    Sentara Recalls Tobramycin Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling Tobramycin 120MG Homepumps because the sterility of the product cannot be guaranteed. The affected lots were compounded in September 2015.

    Product
    Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0618-2016·2016-02-03

    Sentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues

    Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0641-2016·2016-02-03

    Sentara Recalls Gentamicin Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Gentamicin Homepumps because the sterility of the product cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0637-2016·2016-02-03

    Sentara Recalls Compounded Cancidas Due to Sterility Concerns

    Sentara Enterprises is recalling 7 bags of compounded Cancidas (caspofungin acetate) because the sterility of the product cannot be guaranteed.

    Product
    Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0598-2016·2016-02-03

    Pharmakon Recalls Hydromorphone Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling 8,000 units of Hydromorphone HCl 1 mg/mL syringes nationwide because stability data does not support the expiration dates.

    Product
    Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0619-2016·2016-02-03

    Sentara Recalls Potassium Chloride Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Potassium Chloride in D 5 1/2NS home infusion bags because sterility cannot be guaranteed.

    Product
    POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0634-2016·2016-02-03

    Sentara Recalls Ampicillin/Sulbactam Bags Due to Sterility Concerns

    Sentara Enterprises is recalling 9 bags of Ampicillin/Sulbactam 12GM in NS due to a lack of assurance of sterility. The affected products were distributed in Virginia and North Carolina.

    Product
    Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·16V061000·2016-02-03

    Honda and Acura Recall Vehicles Due to Airbag Inflator Rupture Risk

    Honda is recalling specific 2005-2016 Acura and Honda vehicles because the driver's airbag inflator may rupture during a crash, potentially causing serious injury or death.

    Product
    ACURA — ACURA, HONDA RDX, RIDGELINE, CR-V, RL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V060000·2016-02-03

    Subaru Recalls Tribeca Vehicles for Hood Safety System Malfunction

    Subaru is recalling 2006-2014 Tribeca vehicles because the hood may open unexpectedly while driving, potentially blocking the driver's view.

    Product
    SUBARU — SUBARU TRIBECA, B9 TRIBECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V063000·2016-02-03

    GM Recalls Saab and Saturn Vehicles for Air Bag Inflator Defect

    General Motors is recalling specific Saab and Saturn vehicles because the driver's air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    SAAB — SAAB, SATURN 9-5, ASTRA, 9-3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0639-2016·2016-02-03

    Sentara Recalls Clindamycin Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling 6 bags of Clindamycin 120mg in NS Homepumps because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0625-2016·2016-02-03

    Sentara Recalls Hydromorphone HCL Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of Hydromorphone HCL because the sterility of the product cannot be guaranteed.

    Product
    HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0630-2016·2016-02-03

    Sentara Recalls ZOSYN Homepumps Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of ZOSYN (piperacillin/tazobactam) homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.

    Product
    ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0614-2016·2016-02-03

    Sentara Parenteral Amino Acid Infusion Recalled for Sterility Concerns

    Sentara Enterprises is recalling Parenteral Amino Acid Infusion 10% bags because product sterility cannot be guaranteed. The recall affects specific lots compounded in September 2015.

    Product
    Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l)
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0611-2016·2016-02-03

    Sentara Recalls Meropenem Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling Meropenem in NS Homepumps because product sterility cannot be guaranteed. The recall affects 192 bags distributed in Virginia and North Carolina.

    Product
    MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0624-2016·2016-02-03

    Sentara Recalls Ondansetron HCL 8mg Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling 77 bags of Ondansetron HCL 8mg Homepumps because the product's sterility cannot be guaranteed. The affected lots were distributed in Virginia and North Carolina.

    Product
    ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0612-2016·2016-02-03

    Sentara Recalls Daptomycin Syringes Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of CUBICIN (daptomycin) in NS syringes and homepumps because the sterility of the product cannot be guaranteed.

    Product
    CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Hom
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0628-2016·2016-02-03

    Sentara Recalls Invanz Injection Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Invanz (ertapenem) injection homepumps because product sterility cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.

    Product
    Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0644-2016·2016-02-03

    Sentara Recalls Mycamine Micafungin Sodium Due to Sterility Concerns

    Sentara Enterprises is recalling 10 bags of Mycamine (micafungin sodium) 150mg because product sterility cannot be guaranteed.

    Product
    MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0621-2016·2016-02-03

    Sentara Recalls Ceftriaxone Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Ceftriaxone in NS Homepumps because product sterility cannot be guaranteed. The recall affects 82 bags distributed in Virginia and North Carolina.

    Product
    CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0620-2016·2016-02-03

    Sentara Recalls Dextrose-NaCl Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility cannot be guaranteed.

    Product
    Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0638-2016·2016-02-03

    Sentara Recalls AZACTAM Bags Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling 12 bags of AZACTAM (aztreonam) 2GM in NS because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0632-2016·2016-02-03

    Sentara Recalls Penicillin in D5W Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Penicillin in D5W Homepumps because the sterility of the product cannot be guaranteed.

    Product
    PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0640-2016·2016-02-03

    Sentara Recalls Solu-Cortef Syringes Due to Sterility Concerns

    Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS syringes because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0592-2016·2016-02-03

    Pharmakon Recalls Succinylcholine Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 2,750 syringes of Succinylcholine 20 mg/mL because stability data does not support the expiration dates.

    Product
    Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0623-2016·2016-02-03

    Sentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling Vancomycin HCL home infusion bags because the product's sterility cannot be guaranteed. The recall affects bags distributed in Virginia and North Carolina.

    Product
    VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Ho
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0617-2016·2016-02-03

    Sentara Recalls Solumedrol Bags Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling 7 bags of Solumedrol (methylprednisolone succinate) 1GM in NS because product sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0622-2016·2016-02-03

    Sentara Recalls Dobutamine HCL Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling Dobutamine HCL in D5W home infusion bags because the sterility of the product cannot be guaranteed.

    Product
    DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0695-2016·2016-02-03

    Bio-Rad D-10 Rack Loader Recalled for Potential Sample ID Error

    Bio-Rad is recalling D-10 Rack Loaders because a rare configuration issue could assign patient results to incorrect sample IDs.

    Product
    D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0589-2016·2016-02-03

    Pharmakon Recalls Subpotent Epinephrine Injectable Syringes Nationwide

    Pharmakon Pharmaceuticals is recalling 1,150 syringes of Epinephrine (PF) 10 mcg/mL because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·16091·2016-02-03

    Lutron Recalls Roller Shades Due to Falling Impact Hazard

    Lutron Electronics is recalling about 30,000 Serena and SIVOIA QS TRIATHLON roller shades because they can fall from brackets, posing an impact hazard.

    Product
    Roller Shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2016·2016-02-03

    Fresenius Liberty Cycler Peritoneal Dialysis Machines Recalled for Door Latch Defect

    Fresenius Medical Care is recalling 14,094 Liberty Cycler peritoneal dialysis machines because the door latch may not fully close, posing a risk of injury or treatment delay.

    Product
    Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0515-2016·2016-02-03

    Mandarin Oranges Recalled for Possible Glass Contamination

    Milky Way Intl Trading Corp is recalling Mandarin Oranges due to possible glass in the product. The recall affects 8,309 cases distributed to Walgreens stores nationwide.

    Product
    Mandarin Oranges (In Light Syrup), Net Wt. 8oz (227g), Case UPC#: 100-49022-80895-6, Product UPC#: 0-49022-80895-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0616-2016·2016-02-03

    Sentara Recalls Milrinone Infusions Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Milrinone in 0.45% NS homepumps because the sterility of the product cannot be guaranteed.

    Product
    Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0593-2016·2016-02-03

    Pharmakon Recalls Subpotent Midazolam Injectable Syringes Nationwide

    Pharmakon Pharmaceuticals is recalling 210 syringes of Midazolam (PF) 0.5 mg/mL because the drug is subpotent. The recall is voluntary and nationwide.

    Product
    Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·16V062000·2016-02-03

    Forest River Recalls 2016 Surveyor RVs Due to Wiring Defect

    Forest River is recalling 12 model year 2016 Surveyor recreational vehicles because incorrect wiring may allow excessive current, posing an electrocution risk.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0651-2016·2016-02-03

    Midmark Vantage Panoramic X-Ray System Recalled for Collimator Failure

    Midmark Corp dba Progeny Inc is recalling 832 Vantage Panoramic X-Ray Systems because a primary collimator failure may cause unintentional movement without an error message.

    Product
    Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0690-2016·2016-02-03

    Globalmed Logistix Recalls Lipogems SPA Aspiration Cannulae Due to Bending Risk

    Globalmed Logistix is recalling 118 units of Lipogems SPA Aspiration Cannulae because they may bend during procedures. The affected sterile cannulae were distributed to seven states.

    Product
    Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0643-2016·2016-02-03

    Sentara Recalls Dextrose-5% Lactated Ringers Due to Sterility Concerns

    Sentara Enterprises is recalling 7 bags of Dextrose-5% Lactated Ringers because the sterility of the product cannot be guaranteed.

    Product
    Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0613-2016·2016-02-03

    Sentara Recalls Sodium Chloride Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Sodium Chloride Homepumps because the sterility of the product cannot be guaranteed.

    Product
    SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.3
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0615-2016·2016-02-03

    Sentara Recalls Cefazolin Due to Lack of Sterility Assurance

    Sentara Enterprises is recalling specific lots of Cefazolin because the sterility of the product cannot be guaranteed. The affected products were distributed in Virginia and North Carolina.

    Product
    CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0636-2016·2016-02-03

    Sentara Recalls Lactated Ringers Due to Sterility Assurance Concerns

    Sentara Enterprises is recalling specific lots of Lactated Ringers because product sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0600-2016·2016-02-03

    Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 600 syringes of Ketamine 100 mg/mL because stability data does not support the expiration dates.

    Product
    Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0609-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers all lots expiring through November 17, 2015.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0597-2016·2016-02-03

    Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 475 syringes of Morphine Sulfate (PF) 0.5 mg/mL because stability data does not support the expiration dates.

    Product
    Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0586-2016·2016-02-03

    Perrigo Recalls Guaifenesin Liquid Due to Incorrect Dosing Cup Markings

    Perrigo Company PLC is recalling specific lots of Guaifenesin liquid because the included dosing cups have incorrect dose markings.

    Product
    Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for:
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2016·2016-02-03

    Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 250 syringes of Ketamine 50 mg/mL because stability data does not support the expiration dates.

    Product
    Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2016·2016-02-03

    Amerisource Recalls Levofloxacin Tablets Due to Dissolution Failures

    Amerisource Health Services is recalling 3,888 cartons of Levofloxacin 500 mg tablets because they failed dissolution specifications.

    Product
    Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Col
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2016·2016-02-03

    Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling 525 syringes of Morphine Sulfate because stability data does not support the expiration dates.

    Product
    Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0607-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers all lots expiring through November 17, 2015.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2016·2016-02-03

    Pharmakon Recalls Lidocaine HCI Injectable Syringes Due to Stability Data

    Pharmakon Pharmaceuticals is recalling Lidocaine HCI 2% injectable syringes because stability data does not support the expiration dates.

    Product
    Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0587-2016·2016-02-03

    Perrigo Recalls Children's Guaifenesin DM Liquid Due to Dosing Cup Errors

    Perrigo is recalling specific lots of Children's Guaifenesin DM Cherry liquid because the included dosing cups have incorrect dose markings.

    Product
    Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0588-2016·2016-02-03

    Pharmakon Recalls Ephedrine Sulfate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL injectable syringes because stability data does not support the expiration dates.

    Product
    Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0605-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 378 units of Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers lots expiring up to November 17, 2015.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0608-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall affects lots expiring through November 17, 2015.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0606-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. All lots expiring up to 11/17/2015 are affected.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0594-2016·2016-02-03

    Pharmakon Recalls Ondansetron Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 4,100 units of Ondansetron 2 mg/mL injectable syringes because stability data does not support the expiration dates.

    Product
    Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2016·2016-02-03

    Pharmakon Recalls Rocuronium Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 5,875 units of Rocuronium 10 mg/mL syringes because stability data does not support the expiration dates.

    Product
    Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2016·2016-02-03

    Phadia Recalls EliA SmDP Wells Due to Invalid Test Results

    Phadia Ab is recalling 76 units of EliA SmDP Well lot 0018 because nonspecific signals may cause incorrect positive or equivocal test results for systemic lupus erythematosus.

    Product
    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0603-2016·2016-02-03

    Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 5,000 syringes of Midazolam 1 mg/mL because stability data does not support the expiration dates.

    Product
    Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0596-2016·2016-02-03

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because stability data does not support the expiration dates. The recall covers 7,100 units distributed nationwide.

    Product
    Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·16V059000·2016-02-03

    Forest River Recalls 2016 Wildcat Trailers for Incorrect Weight Placards

    Forest River is recalling 52 model year 2016 Wildcat recreational trailers because they may have incorrect Federal placards with a reduced Gross Axle Weight Rating.

    Product
    FOREST RIVER — FOREST RIVER WILDCAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0590-2016·2016-02-03

    Pharmakon Recalls Phenylephrine Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Phenylephrine injectable syringes because stability data does not support the expiration dates.

    Product
    Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2016·2016-02-03

    Pharmakon Recalls Glycopyrrolate Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 1,530 syringes of Glycopyrrolate 0.2 mg/mL because stability data does not support the expiration dates.

    Product
    Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2016·2016-02-03

    Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 665 syringes of Midazolam (PF) because stability data does not support the expiration dates. The recall is nationwide.

    Product
    Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide

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