The Recall Desk

Archive

May 2017 recalls

771 recalls were announced in May 2017.

What the numbers show

Critical
45
Severe
174
High
254
Moderate
259
Low
39

Of the 771 recalls this month scored against our rubric, 6% are Critical, 23% are Severe.

Which agencies issued them

101–200 of 771

  • ModerateFDA (Devices)·Z-2156-2017·2017-05-31

    Siemens AXIOM Sensis Diagnostic Computer Recalled for Dust-Related Failures

    Siemens Medical Solutions is recalling 4,095 AXIOM Sensis diagnostic computers because dust accumulation can cause system failures, potentially interrupting clinical treatments.

    Product
    AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0792-2017·2017-05-31

    Fagron Recalls Estrone Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estrone for Prescription Compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0816-2017·2017-05-31

    Advanced Pharma Recalls Methohexital Sodium Due to Latex Labeling

    Advanced Pharma Inc. is recalling Methohexital Sodium because the product may contain latex but lacks proper labeling.

    Product
    Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0808-2017·2017-05-31

    Advanced Pharma Recalls Sufentanil Citrate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Sufentanil Citrate because the product may contain latex, which is not currently disclosed on the label.

    Product
    Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0818-2017·2017-05-31

    Advanced Pharma Recalls Vancomycin HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Vancomycin HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2017·2017-05-31

    Advanced Pharma Recalls Ondansetron HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Ondansetron HCl because the product labeling may not adequately disclose the presence of synthetic or natural latex.

    Product
    Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2017·2017-05-31

    Advanced Pharma Recalls Phenylephrine HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Phenylephrine HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2017·2017-05-31

    Bard StatLock IV Premium Catheter Stabilization Device Recalled for Sizing Error

    Bard Access Systems is recalling 4,500 units of StatLock IV Premium Catheter Stabilization Devices because they may contain incorrectly sized retainer clips.

    Product
    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall

    St. Jude Medical is updating software and hardware for HeartMate II LVAS devices to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0847-2017·2017-05-31

    Advanced Pharma Recalls Cardioplegic Solution for Latex Labeling Defect

    Advanced Pharma Inc. is recalling Cardioplegic Solution Maintenance due to a labeling error regarding potential latex content.

    Product
    Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0798-2017·2017-05-31

    Advanced Pharma Recalls RECK PeriCapsular Injection Due to Latex Labeling

    Advanced Pharma Inc. is recalling RECK PeriCapsular injection because the product may contain synthetic or natural latex, which is not clearly labeled.

    Product
    RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0834-2017·2017-05-31

    Advanced Pharma Recalls Nicardipine HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Nicardipine HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0800-2017·2017-05-31

    Advanced Pharma Recalls Ofirmev Injection Due to Latex Labeling

    Advanced Pharma Inc. is recalling Ofirmev (Acetaminophen) injection because the product may contain synthetic or natural latex, which is not currently classified in the labeling.

    Product
    Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2017·2017-05-31

    Advanced Pharma Recalls Ephedrine Sulfate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Ephedrine Sulfate because the product may contain latex but lacks proper labeling.

    Product
    Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0844-2017·2017-05-31

    Advanced Pharma Recalls Bumetanide Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Bumetanide because the product labeling fails to disclose that it may contain synthetic or natural latex.

    Product
    Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0860-2017·2017-05-31

    Mylan Recalls Tarina Fe 1/20 Tablets Due to Chemical Contamination

    Mylan Pharmaceuticals is recalling Tarina Fe 1/20 tablets due to chemical contamination from paint thinner vapors during manufacturing.

    Product
    Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0812-2017·2017-05-31

    Advanced Pharma Recalls Morphine Sulfate for Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Morphine Sulfate because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2017·2017-05-31

    MesaLabs Conductivity Standard Solution Recalled for Specification Failure

    Mesa Laboratories is recalling 9,900 units of Conductivity/TDS Calibrator Solution because the product failed to meet specifications. The solution is used for calibrating hemodialysis equipment and does not contact patients.

    Product
    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells toget
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2017·2017-05-31

    Advanced Pharma Recalls Ketamine HCl for Potential Latex Content

    Advanced Pharma Inc. is recalling all lots of Ketamine HCl because the product may contain synthetic or natural latex.

    Product
    Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0837-2017·2017-05-31

    Advanced Pharma Recalls Esmolol HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all Esmolol HCl products because the labeling does not indicate that the products may contain synthetic or natural latex.

    Product
    Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2017·2017-05-31

    Advanced Pharma Recalls Hydromorphone HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Hydromorphone HCl because the product labeling does not properly disclose that it may contain synthetic or natural latex.

    Product
    Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0838-2017·2017-05-31

    Advanced Pharma Recalls Glycopyrrolate for Potential Latex Content

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Glycopyrrolate because the product may contain synthetic or natural latex.

    Product
    Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2017·2017-05-31

    Advanced Pharma Recalls Betamethasone Products Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling Betamethasone Sodium Phosphate & Betamethasone Acetate products because they may contain latex but lack appropriate labeling.

    Product
    Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0819-2017·2017-05-31

    Advanced Pharma Recalls Penicillin G Potassium for Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Penicillin G Potassium because the product may contain latex but lacks appropriate labeling.

    Product
    Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0835-2017·2017-05-31

    Advanced Pharma Recalls Rocuronium Bromide Due to Latex Labeling

    Advanced Pharma Inc. is recalling all strengths and forms of Rocuronium Bromide because the product may contain latex without proper labeling.

    Product
    Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0861-2017·2017-05-31

    Mylan Recalls Norethindrone Acetate and Ethinyl Estradiol Tablets Due to Contamination

    Mylan Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to chemical contamination from paint thinner vapors during facility repairs.

    Product
    NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL — NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0831-2017·2017-05-31

    Advanced Pharma Recalls Succinylcholine Chloride for Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Succinylcholine Chloride because the product may contain latex but lacks proper labeling.

    Product
    Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2128-2017·2017-05-31

    Teleflex Medical Recalls PE Connector 3/8 Y 20/BX Due to Missing Expiration Date

    Teleflex Medical is recalling 19,043 units of PE Connector 3/8 Y 20/BX because the expiration date is missing from the labeling, creating a risk of using expired product.

    Product
    PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0806-2017·2017-05-31

    Advanced Pharma Recalls Early Baby TPN Due to Latex Labeling

    Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) because the product may contain synthetic or natural latex, which is not currently labeled.

    Product
    Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0802-2017·2017-05-31

    Advanced Pharma Recalls NICU Starter TPN Due to Latex Labeling

    Advanced Pharma Inc. is recalling NICU Starter TPN products because they may contain synthetic or natural latex without proper labeling.

    Product
    NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2017·2017-05-31

    Advanced Pharma Recalls Heparin Sodium Due to Latex Labeling

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Heparin sodium because the product may contain synthetic or natural latex without proper labeling.

    Product
    Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0809-2017·2017-05-31

    Advanced Pharma Recalls Fentanyl Citrate Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Fentanyl Citrate because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0866-2017·2017-05-31

    Gentell Recalls Moisture Barrier Cream Due to Manufacturing Deviations

    Gentell, Inc. is recalling 65 gallons of Shield and Protect Moisture Barrier Cream because it may not meet cGMP requirements.

    Product
    Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0805-2017·2017-05-31

    Advanced Pharma Recalls Early TPN Neonatal Products for Latex Labeling

    Advanced Pharma Inc. is recalling Early TPN (Neonatal) products nationwide due to a labeling error regarding potential latex content.

    Product
    Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0850-2017·2017-05-31

    Advanced Pharma Recalls Sodium Phosphate for Latex Labeling Defect

    Advanced Pharma Inc. is recalling Sodium Phosphate products because they may contain latex but lack proper labeling. The recall covers all strengths and dosage forms distributed nationwide.

    Product
    Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0801-2017·2017-05-31

    Advanced Pharma Recalls Ropi Epi Clon Injection Due to Latex Labeling

    Advanced Pharma Inc. is recalling Ropi/ Epi/ Clon PeriCapsular injection because the product may contain latex and lacks appropriate labeling.

    Product
    Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0830-2017·2017-05-31

    Advanced Pharma Recalls Amiodarone Due to Potential Latex Content

    Advanced Pharma Inc. is recalling all Amiodarone products due to a labeling issue regarding potential synthetic or natural latex content.

    Product
    Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2121-2017·2017-05-31

    Medtest Recalls Pointe Scientific Chemistry Controls Due to Mean Assignment Error

    Medtest Holdings is recalling Pointe Scientific Chemistry Controls Level I and II because the original mean assigned to the controls was too high, resulting in a new assigned mean outside the published range.

    Product
    Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0857-2017·2017-05-31

    Sun Pharmaceutical Recalls Children's Cetirizine Tablets for Hardness Issues

    Sun Pharmaceutical Industries is recalling 13,200 bottles of Children's Cetirizine Hydrochloride Chewable Tablets due to out-of-specification tablet hardness.

    Product
    Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0859-2017·2017-05-31

    Qualitest Recalls Hydrocortisone Lotion for Excessive Potency

    Qualitest Pharmaceuticals is recalling 109,620 bottles of Hydrocortisone Lotion, USP, 2.5% because the product is superpotent, meaning it contains more active ingredient than specified.

    Product
    HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0858-2017·2017-05-31

    Strides Pharma Recalls Benzonatate Capsules for Stability Failure

    Strides Pharma Inc. is recalling Benzonatate capsules due to out-of-specification preservative levels. The FDA classified this as a Class III recall.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowNHTSA·17V352000·2017-05-31

    Volkswagen Recalls 2017 Jetta for VIN Marking Mismatch

    Volkswagen is recalling 2017 Jetta vehicles because the VIN on the body does not match the VIN plate near the windshield, violating federal certification regulations.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2250-2017·2017-05-31

    Schiff Move Free Advanced Tablets Recalled for Incorrect Packaging

    RB Manufacturing is recalling Schiff Move Free Advanced Plus MSM & Vitamin D3 tablets due to incorrect packaging.

    Product
    Schiff Move Free Advanced Plus MSM & Vitamin D3 with Glucosamine + Chondroitin, 80 Coated Tablets, Dietary Supplement, Product item number: 20525-11873
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V348000·2017-05-30

    Pierce Fire Trucks Recalled for Rear Axle Shaft Defect

    Pierce Manufacturing is recalling 1999-2013 fire trucks with electric All-steer rear steering due to improperly heat-treated axle shafts that may break.

    Product
    PIERCE — PIERCE QUANTUM, ARROW XT, VELOCITY, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V350000·2017-05-30

    Jayco Eagle Travel Trailer Recalled for Incorrect Weight Rating Label

    Jayco is recalling 2018 Eagle TT 330RSTS trailers because the Federal Placard lists an incorrect Gross Axle Weight Rating, which could lead to overloading and loss of control.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V347000·2017-05-30

    KZRV Venom Travel Trailer Recall for Fire Risk

    KZRV is recalling 2016-2018 Venom fifth-wheel travel trailers with outside kitchens because a missing copper pipe may cause the gas line to melt and start a fire.

    Product
    KZRV — KZRV VENOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·057-2017·2017-05-27

    Readfield Meats Recalls Beef Trimming Products Due to Possible Adulteration

    Readfield Meats is recalling approximately 45,985 pounds of beef trimming products because they were distributed to non-federally inspected establishments where sufficient further processing could not be verified.

    Product
    Dominion Foods Group LLC — Readfield Meats, Inc. Recalls Beef Trimming Products Due to Possible Adulteration
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V345000·2017-05-26

    VanLeigh Recalls 2015-2018 Vilano Trailers Due to Spare Tire Winch Defect

    VanLeigh is recalling 2015-2018 Vilano fifth-wheel recreational trailers because the spare tire winch may not be properly fastened, posing a crash risk if the tire falls off.

    Product
    VANLEIGH — VANLEIGH VILANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2017·2017-05-26

    Cauldron Soups Recalls Beef Broth Products Produced Without Federal Inspection

    Cauldron Soups, LLC is recalling approximately 5,163 pounds of beef broth products produced without federal inspection. No illnesses have been reported.

    Product
    Somi Foods, Inc — Cauldron Soups, LLC Recalls Beef Broth Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighCPSC·17168·2017-05-26

    CPSC Recalls Kobalt and Greenworks Cordless Lawn Mowers Due to Fire Hazard

    CPSC is recalling about 28,000 Kobalt and Greenworks cordless electric lawn mowers because the circuit board can short circuit and catch fire. No injuries have been reported.

    Product
    Cordless electric lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V344000·2017-05-26

    Gulf Stream Travel Trailer Recall for Incorrect Tire Identification Label

    Gulf Stream is recalling 2015-2018 Vista and Vintage Cruiser travel trailers because the tire label lists incorrect tire specifications, which could lead to installing the wrong replacement tires.

    Product
    GULF STREAM — GULF STREAM VISTA CRUISER, VINTAGE CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V346000·2017-05-26

    Forest River Recalls 2016-2017 Vibe Trailers for Incorrect Tire Placard

    Forest River is recalling 2016-2017 Vibe recreational trailers because the Federal Placard lists incorrect tire size and pressure information, which could lead to improper tire maintenance.

    Product
    FOREST RIVER — FOREST RIVER VIBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·055-2017·2017-05-25

    Golden Gourmet Recalls Frozen Waffle and Turkey Sausage Products Due to Listeria

    Golden Gourmet is recalling approximately 5,248 pounds of frozen waffle and turkey sausage products due to possible Listeria monocytogenes contamination. The products were shipped to institutions in six states.

    Product
    Golden Gourmet, LLC — Golden Gourmet Recalls Frozen Waffle and Turkey Sausage Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·17V340000·2017-05-25

    Eldorado Amerivan 10 Recall for Potential Trailing Arm Mount Failure

    Eldorado Mobility is recalling 2017 Amerivan 10 lowered-floor vehicles because trailing arm mounts may break, potentially causing loss of steering control.

    Product
    ELDORADO — ELDORADO AMERIVAN 10
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V341000·2017-05-25

    Jaguar Recalls 2018 F-TYPE for Turn Signal Reminder Defect

    Jaguar is recalling 2018 F-TYPE vehicles with Highline headlamps because the turn signal reminder may not flash or chime faster if a signal fails, increasing crash risk.

    Product
    JAGUAR — JAGUAR F-TYPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17167·2017-05-25

    Extech Recalls Digital Clamp Meters Due to Electrocution Hazard

    Extech is recalling specific digital clamp meters because they may display incorrect voltage readings, posing an electrocution risk to operators.

    Product
    Digital clamp meters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2235-2017·2017-05-24

    Del Mar IQF Chopped Spinach Recalled for Listeria Monocytogenes

    Del Mar Food Products Corp. is recalling IQF Chopped Spinach after a customer reported a positive Listeria Monocytogenes test result.

    Product
    I.Q.F Chopped Spinach, Del Mar Foods Product Corp; 35 lb. Net Weight. brown case fiber with polyliner Del Mar Food Products; Watsonville, CA 95077
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-2038-2017·2017-05-24

    Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues

    Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-1
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-2240-2017·2017-05-24

    Wegmans Potato Salad Recalled for Undeclared Egg Allergen

    ASK Foods Inc is recalling Wegmans Family Pack Potato Salad because the containers were labeled with a statement from a different product, failing to declare egg.

    Product
    Wegmans Wegmans Family Pack Potato Salad, Net Wt. 48 OZ; Ingredients: Pasta Shells***Water, Cucumbers, Feta Cheese...ect; Allergens: Contains Milk and Wheat; Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603; Sell By: 5/7/17 3379-4; UPC: 7789024678
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-2217-2017·2017-05-24

    Whole Foods Recalls Holiday Cookies Due to Undeclared Egg

    Whole Foods Market is recalling 9,936 decorated holiday cookies sold in the Bay Area because they contain an undeclared egg allergen.

    Product
    Decorated (sugared) holiday cookies sold in the shape of purple eggs, pink bunnies or yellow chicks. These cookies were sold in the self service cookie display.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2037-2017·2017-05-24

    Abbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Trek RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 10
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0737-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 200 vials of TRI MIX 10/30/0.5 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0725-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the compounded drugs.

    Product
    HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0720-2017·2017-05-24

    Key Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 72 vials of HCG injections because the firm cannot assure the sterility of the compounded drugs.

    Product
    HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0783-2017·2017-05-24

    Key Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Injection due to a lack of assurance of sterility.

    Product
    TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2017·2017-05-24

    Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 25 vials of Methyl-B12 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0771-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot assure the products are sterile.

    Product
    PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0742-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 25 vials of TRI MIX 20/20/1 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0724-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.

    Product
    HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0714-2017·2017-05-24

    Key Pharmacy Recalls DMPS Acid Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 214 vials of DMPS Acid injections because the firm cannot assure the sterility of the product.

    Product
    DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0780-2017·2017-05-24

    Key Pharmacy Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Sodium Chloride Inhalation Solution because the firm cannot assure the sterility of the product.

    Product
    SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0782-2017·2017-05-24

    Key Pharmacy Recalls Testosterone Cypionate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Cypionate injections because the firm cannot guarantee the products are sterile.

    Product
    TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0750-2017·2017-05-24

    FDA Recalls Key Pharmacy Compounded Sterile Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX sterile compounded injections due to a lack of assurance of sterility. The affected vials were distributed in the U.S., Australia, and Canada.

    Product
    TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0736-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0759-2017·2017-05-24

    Key Pharmacy Recalls Sterile Ophthalmic Compounded Drug Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling a specific lot of sterile compounded ophthalmic drug due to a lack of assurance of sterility.

    Product
    VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0726-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.

    Product
    HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0778-2017·2017-05-24

    Key Pharmacy Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Sodium Bicarbonate Injection because the firm cannot guarantee the product is sterile.

    Product
    SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2097-2017·2017-05-24

    Ion Beam Applications Recalls Two Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.

    Product
    Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0766-2017·2017-05-24

    Key Pharmacy Recalls GSH/NAC Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling GSH/NAC inhalation solution because the firm cannot assure the product is sterile.

    Product
    GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0729-2017·2017-05-24

    Key Pharmacy Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injections because the firm cannot assure the sterility of the product.

    Product
    PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0739-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling a specific lot of TRI MIX injection due to a lack of assurance of sterility.

    Product
    TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0752-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 5/30/0.5 injection vials because the firm cannot ensure the sterile compounded drugs are free from contamination.

    Product
    TRI MIX 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0774-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 2% injections because the firm cannot guarantee the products are sterile.

    Product
    PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0775-2017·2017-05-24

    FDA Recalls Compounded Progesterone Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling compounded progesterone injections because the firm cannot ensure the products are sterile.

    Product
    PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0761-2017·2017-05-24

    Key Pharmacy Recalls Cyanocobalamin Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Cyanocobalamin injections because the firm cannot ensure the products are sterile.

    Product
    CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0710-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF SDV 5mg/mL injections because the firm cannot assure the sterility of the compounded drugs.

    Product
    5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0717-2017·2017-05-24

    Key Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.

    Product
    FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0786-2017·2017-05-24

    Key Pharmacy Recalls Vitamin D3 Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Vitamin D3 in Olive Oil Injection due to a lack of assurance of sterility.

    Product
    VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0707-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF injections because the firm cannot assure the products are sterile.

    Product
    5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0746-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0776-2017·2017-05-24

    Key Pharmacy Recalls Pyridoxal-5-Phosphate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 100mg/mL injections due to a lack of assurance of sterility.

    Product
    PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0748-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/4 injection vials because the firm cannot assure the sterility of the product.

    Product
    TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0740-2017·2017-05-24

    FDA Recalls Key Pharmacy Compounded Sterile Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2112-2017·2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.

    Product
    OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0731-2017·2017-05-24

    Key Pharmacy Recalls PGE1 Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling PGE1 MDV 20mcg/mL injections due to a lack of assurance of sterility. The affected products were distributed in the U.S., Australia, and Canada.

    Product
    PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide

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