The Recall Desk

Archive

May 2013 recalls

607 recalls were announced in May 2013.

What the numbers show

Critical
23
Severe
225
High
139
Moderate
183
Low
37

Of the 607 recalls this month scored against our rubric, 4% are Critical, 37% are Severe.

Which agencies issued them

601–607 of 607

  • ModerateFDA (Devices)·Z-1175-2013·2013-05-01

    DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.

    Product
    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1176-2013·2013-05-01

    DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.

    Product
    ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-269-2013·2013-05-01

    Mylan Recalls Lisinopril Tablets With Incorrect Identifier Codes

    Mylan Pharmaceuticals is recalling 2,405 bottles of Lisinopril 10 mg tablets because the pills have the wrong ID code imprinted on them.

    Product
    Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1161-2013·2013-05-01

    Ortho-Clinical Diagnostics Recalls Vitros Anti-HBs Reagent Packs Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling specific lots of Vitros Anti-HBs Reagent Packs because they may fail to obtain a valid calibration.

    Product
    VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1162-2013·2013-05-01

    Sirtex SIR-yttrium 90 microspheres recalled for incorrect expiration date

    Sirtex Medical Limited is recalling 21 doses of SIR-yttrium 90 microspheres due to an incorrect expiration date. The product is used to treat unresectable metastatic liver tumors.

    Product
    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1350-2013·2013-05-01

    Kwong Hung Seng Thin Soy Sauce Recalled for Insanitary Conditions

    Royal Foods, Inc. is recalling Kwong Hung Seng Thin Soy Sauce due to insanitary conditions found during a state audit, including a leaking roof and rodent activity.

    Product
    Kwong Hung Seng Sauce - Thin Soy Sauce Product is packaged in bottles Net Wt 19 Fl oz - 12 bottles per case
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1338-2013·2013-05-01

    Nexgen Pharma Recalls L-Arginine Supplement Due to Subpotency

    Nexgen Pharma is recalling a specific lot of L-Arginine L-Ornithine Alpha Lipoic Acid capsules because the Alpha Lipoic Acid ingredient is subpotent.

    Product
    Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution…
    Category
    Food
    Distribution
    Distributed nationwide

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