The Recall Desk

Archive

February 2018 recalls

833 recalls were announced in February 2018.

What the numbers show

Critical
22
Severe
228
High
281
Moderate
281
Low
21

Of the 833 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.

Which agencies issued them

1–100 of 833

  • CriticalFDA (Devices)·Z-0583-2018·2018-02-28

    Medtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk

    Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0587-2018·2018-02-28

    Medtronic Recalls Evera ICDs Due to Possible Therapy Prevention

    Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0452-2018·2018-02-28

    Pharmedium Recalls Ketamine HCl Injection Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Ketamine HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.

    Product
    Ketamine HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0582-2018·2018-02-28

    Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk

    Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Am
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2018·2018-02-28

    Pharmedium Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Ephedrine Sulfate Injection due to a lack of sterility assurance.

    Product
    Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2018·2018-02-28

    Pharmedium Recalls Hydromorphone HCl in 5% Dextrose Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Hydromorphone HCl in 5% Dextrose in all strengths and packaging due to a lack of sterility assurance.

    Product
    HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0441-2018·2018-02-28

    Pharmedium Recalls Ketamine HCl Injection Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Ketamine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0533-2018·2018-02-28

    FDA Recalls Vardenafil HCl for Prescription Compounding Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Vardenafil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.

    Product
    Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2018·2018-02-28

    Pharmedium Recalls Phenylephrine HCl Injections Due To Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Phenylephrine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0455-2018·2018-02-28

    Pharmedium Recalls Lidocaine HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Lidocaine HCl in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.

    Product
    Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2018·2018-02-28

    Pharmedium Recalls Methadone HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Methadone HCl Injection in all strengths and packaging due to a lack of sterility assurance.

    Product
    Methadone HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0443-2018·2018-02-28

    Pharmedium Recalls Adenosine Injection Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Adenosine Injection because of a lack of sterility assurance. The recall covers products distributed nationwide.

    Product
    Adenosine Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0433-2018·2018-02-28

    Pharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl Injection due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2018·2018-02-28

    Pharmedium Recalls Atropine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Atropine Sulfate Injection nationwide due to a lack of sterility assurance.

    Product
    Atropine Sulfate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0819-2018·2018-02-28

    Flexfrost Protein Ice Cream Recalled for Insufficient Pasteurization Monitoring

    Flexfrost is recalling 2,927 cups of vanilla protein ice cream because the Ohio Department of Agriculture found insufficient pasteurization monitoring measures.

    Product
    Flexfrost Protein Ice Cream Vanilla Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0432-2018·2018-02-28

    Pharmedium Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Ephedrine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.

    Product
    Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2018·2018-02-28

    Pharmedium Recalls Esmolol HCl Due to Lack of Sterility Assurance

    Pharmedium Services, LLC is recalling Esmolol HCl in all strengths and packaging due to a lack of sterility assurance.

    Product
    Esmolol HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2018·2018-02-28

    Pharmedium Recalls Meperidine HCl Injections Due To Sterility Concerns

    Pharmedium Services, LLC is recalling Meperidine HCl in 0.9% Sodium Chloride injections nationwide due to a lack of sterility assurance.

    Product
    Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0828-2018·2018-02-28

    Gobugi Holdings Recalls Dried Anchovies Due to Botulism Risk

    Gobugi Holdings Inc. is recalling dried anchovies in California and Oregon because the product is uneviscerated and may be contaminated with Clostridium botulinum.

    Product
    Dried Anchovy, size (S), (M), (L), packaged in 1.5 kg. cardboard box without brand name. The cardboard box states "***IMPORTED BY: GOBUGI HOLDINGS, INC. 4520 SW 110TH AVE. BEAVERTON, OREGON 97005***PRODUCT OF REPUBLIC OF KOREA***". Small (S) Anchovy Korea, packaged in a clear
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0437-2018·2018-02-28

    Pharmedium Recalls Morphine Sulfate in 5% Dextrose Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Morphine Sulfate in 5% Dextrose in all strengths and packaging due to a lack of sterility assurance.

    Product
    Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0488-2018·2018-02-28

    FDA Recalls Estradiol USP for Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Estradiol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.

    Product
    Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highl
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0436-2018·2018-02-28

    Pharmedium Recalls Morphine Sulfate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Morphine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.

    Product
    Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0589-2018·2018-02-28

    Medtronic Visia AF ICDs Recalled for Potential Therapy Failure

    Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0439-2018·2018-02-28

    Pharmedium Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Fentanyl Citrate in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0642-2018·2018-02-28

    Allen Medical Systems Recalls Radiolucent Surgery Spine Frames

    Allen Medical Systems is recalling 161 Radiolucent Surgery Spine Frames because the base may crack during patient transfer.

    Product
    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0431-2018·2018-02-28

    Pharmedium Recalls Fentanyl and Bupivacaine Injections Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Fentanyl Citrate and Bupivacaine HCl injections due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0638-2018·2018-02-28

    ROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors

    Zimmer Biomet is recalling 16 ROSA Brain 3.0 Stereotaxic instruments because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0446-2018·2018-02-28

    Pharmedium Recalls Potassium Chloride in 5% Dextrose Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 5% Dextrose due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2018·2018-02-28

    Pharmedium Recalls Ropivacaine HCl Injection Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Ropivacaine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2018·2018-02-28

    Pharmedium Recalls Methadone HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Methadone HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0428-2018·2018-02-28

    Pharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl in Sodium Chloride 0.9% due to a lack of sterility assurance.

    Product
    HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0438-2018·2018-02-28

    Pharmedium Recalls Lidocaine HCl Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Lidocaine HCl due to a lack of sterility assurance. The recall covers products distributed nationwide in the U.S.

    Product
    Lidocaine HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2018·2018-02-28

    Pharmedium Recalls All Nicardipine HCl Due to Sterility Assurance Issues

    Pharmedium Services, LLC is recalling all lots of Nicardipine HCl because the product lacks sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.

    Product
    Nicardipine HCl in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2018·2018-02-28

    Pharmedium Recalls Labetalol HCl Infusions Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling Labetalol HCl in 0.9% Sodium Chloride infusions nationwide due to a lack of sterility assurance.

    Product
    Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0537-2018·2018-02-28

    FDA Recalls Methylcobalamin Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Methylcobalamin (Vitamin B12) for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical I
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0435-2018·2018-02-28

    Pharmedium Recalls Midazolam HCl in 5% Dextrose Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Midazolam HCl in 5% Dextrose due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2018·2018-02-28

    Pharmedium Recalls Midazolam HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Midazolam HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0825-2018·2018-02-28

    National Frozen Foods Recalls Frozen Vegetable Blends Due to Listeria Risk

    National Frozen Foods Corporation is recalling specific lots of Monarch and Simplot Classic frozen vegetable blends due to potential Listeria monocytogenes contamination.

    Product
    IQF blend product sold as Not Ready To Eat (NRTE) product for use in foodservice or manufacturing applications. The product cases are labeled with instructions to cook product. -Monarch brand, IQF frozen Capri Vegetable Blend, Ingredients: Carrots, Green Beans, Yellow Squash,
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-0429-2018·2018-02-28

    Pharmedium Recalls Bupivacaine HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Bupivacaine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers 297 bags distributed nationwide.

    Product
    Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2018·2018-02-28

    Pharmedium Recalls Midazolam HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Midazolam HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.

    Product
    Midazolam HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0430-2018·2018-02-28

    Pharmedium Recalls Fentanyl and Ropivacaine Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Fentanyl Citrate and Ropivacaine HCl injections because of a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.

    Product
    Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0639-2018·2018-02-28

    Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error

    Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0641-2018·2018-02-28

    Allen Medical Bow Frame Recalled Due to Potential Base Cracking

    Allen Medical Systems is recalling 161 Bow Frame Model A-70800 surgical platforms because the base may crack when patients are transferred onto the device.

    Product
    Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2018·2018-02-28

    Pharmedium Recalls Rocuronium Bromide Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all Rocuronium Bromide products due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Rocuronium Bromide in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2018·2018-02-28

    Pharmedium Recalls Glycopyrrolate Due to Lack of Sterility Assurance

    Pharmedium Services, LLC is recalling all strengths and packaging of Glycopyrrolate due to a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.

    Product
    Glycopyrrolate in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0462-2018·2018-02-28

    Pharmedium Recalls Vecuronium Bromide Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Vecuronium Bromide in Sterile Water for Injection due to a lack of sterility assurance. The recall covers all lots remaining within expiry nationwide.

    Product
    Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2018·2018-02-28

    Pharmedium Recalls Ropivacaine HCl Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Ropivacaine HCl Injection in all strengths and packaging due to a lack of sterility assurance.

    Product
    Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2018·2018-02-28

    Pharmedium Recalls Dexamethasone Sodium Phosphate Infusions Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, doses, and packaging due to a lack of sterility assurance.

    Product
    Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0469-2018·2018-02-28

    Pharmedium Recalls Nicardipine HCl Infusions Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Nicardipine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2018·2018-02-28

    Pharmedium Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Fentanyl Citrate Injection in all strengths and packaging due to a lack of sterility assurance.

    Product
    Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0440-2018·2018-02-28

    Pharmedium Recalls Potassium Chloride Infusions Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0640-2018·2018-02-28

    GastriSail Gastric Positioning Device Recalled Due to Perforation Reports

    FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.

    Product
    GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0816-2018·2018-02-28

    Flexfrost Protein Ice Cream Recalled for Insufficient Pasteurization Monitoring

    Flexfrost is recalling Cinnamon Chai Protein Ice Cream because the Ohio Department of Agriculture found insufficient pasteurization monitoring measures.

    Product
    Flexfrost Protein Ice Cream Cinnamon Chai Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0586-2018·2018-02-28

    Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk

    Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2018·2018-02-28

    Medtronic Viva CRT-D Recall for Possible Prevention of Therapy

    Medtronic is recalling 951 Viva CRT-D devices due to a potential issue that may prevent high and low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2018·2018-02-28

    Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers

    Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

    Product
    PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0637-2018·2018-02-28

    DeRoyal recalls custom sterile surgical packs with Terumo valve defect

    DeRoyal Industries Inc is recalling 181 custom sterile surgical packs distributed in New York due to a Terumo valve defect causing no flow.

    Product
    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0636-2018·2018-02-28

    FDA Recalls Endo GIA Auto Suture Units Due to Safety Interlock Failure

    The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0690-2018·2018-02-28

    Arrow International Recalls PICC Powered by VPS Stylet Kits

    Arrow International is recalling 601 PICC powered by VPS Stylet kits because they may contain an incorrect catheter length.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0671-2018·2018-02-28

    Med Tec Protura Software Recalled for Pedestal Coordinate Errors

    Med Tec Inc is recalling Protura software versions that may fail to update pedestal location data, potentially affecting treatment table movements.

    Product
    Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interfac
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0685-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2018·2018-02-28

    Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk

    Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.

    Product
    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0672-2018·2018-02-28

    Ethicon Recalls Disposable Curved Circular Staplers Due to Malformed Staple Risk

    Ethicon Endo-Surgery Inc is recalling specific lots of disposable curved circular staplers because they may create staples that do not meet height specifications, resulting in malformed staples.

    Product
    Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0646-2018·2018-02-28

    Medtronic Cardiotomy Reservoir Recall for Possible Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy Venous Reservoirs due to a possible sterile barrier breach in the pouch.

    Product
    Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0823-2018·2018-02-28

    Holsum Baking Recalls Frozen Biscuits Due to Listeria Test Result

    Holsum Baking Company Warehouse is recalling frozen unbaked biscuits sold as Hilltop Hearth, Mary B's, and Marshall due to a positive Listeria monocytogenes test.

    Product
    Frozen Unbaked Biscuits sold under the brand names of Hilltop Hearth, Mary B's & Marshall.
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-0645-2018·2018-02-28

    Medtronic Recalls Affinity NT Cardiotomy Reservoirs Due to Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy/Venous Reservoirs because of a possible sterile barrier breach in the pouch.

    Product
    Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed whi
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0644-2018·2018-02-28

    Innovasis Recalls Nine Lots of 8.5 mm Polyaxial Pedicle Screws

    Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws due to a risk of breakage. The recall covers 1,010 parts distributed in the United States.

    Product
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumba
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0824-2018·2018-02-28

    National Frozen Foods Recalls Green Beans Due to Listeria Risk

    National Frozen Foods Corporation is recalling frozen green beans due to potential Listeria monocytogenes contamination. The product is sold for foodservice and manufacturing use.

    Product
    IQF Green beans, sold as Not Ready To Eat (NRTE) product for use in foodservice or manufacturing applications. The product cases are labeled with instructions to cook product. -No brand name, NFFC item #15001-01070, no UPC, packaged in 30 lbs. case. -Bountiful Harvest Foun
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0687-2018·2018-02-28

    Cosman Medical Recalls Nitinol TC Reusable Electrodes Due to Epoxy Damage

    Cosman Medical is recalling Nitinol TC Reusable Electrodes because epoxy damage after reprocessing can prevent the removal of blood and tissue residuals.

    Product
    Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2018·2018-02-28

    Vygon Recalls 3-Way Stopcocks Due to Packaging Sterility Concerns

    Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks because packaging adhesive issues may compromise product sterility.

    Product
    3-Way Standardbore Stopcock. Product Code: AMS-100.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0650-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0815-2018·2018-02-28

    Flexfrost Protein Ice Cream Recalled for Insufficient Pasteurization Monitoring

    Flexfrost is recalling 1200/4 oz cups of Chocolate Protein Ice Cream due to insufficient pasteurization monitoring measures identified by the Ohio Department of Agriculture.

    Product
    Flexfrost Protein Ice Cream Chocolate Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0585-2018·2018-02-28

    Medtronic Recalls 951 Evera MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Evera MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy. Patients should contact their healthcare provider.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Produ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2018·2018-02-28

    Synthes LCP Drill Sleeve Recall Due to Connection and Alignment Issues

    Synthes, Inc. is recalling LCP Drill Sleeve 1.5 Drill Bits because they may fail to attach to plates, potentially causing surgical delays or off-center drilling.

    Product
    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0655-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide

    Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters because they may contain the incorrect Springwire Guide.

    Product
    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2018·2018-02-28

    Pentax Video Duodenoscope Recalled to Mitigate Infection Risk

    Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.

    Product
    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2018·2018-02-28

    Medtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Visia AF MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2018·2018-02-28

    Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error

    Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.

    Product
    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0818-2018·2018-02-28

    Flexfrost Protein Ice Cream Recalled for Insufficient Pasteurization Monitoring

    Flexfrost is recalling Mint Chip Protein Ice Cream because the Ohio Department of Agriculture found insufficient pasteurization monitoring measures.

    Product
    Flexfrost Protein Ice Cream Mint Chip Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0651-2018·2018-02-28

    Arrow International Recalls Central Venous Catheter Kits with Incorrect Guide

    Arrow International is recalling 5,926 central venous catheterization kits distributed nationwide because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0536-2018·2018-02-28

    Biotin USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Biotin USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.

    Product
    Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Desoximetasone USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding due to a lack of stability data and controls supporting the expiration date.

    Product
    Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Stanozolol USP Due to CGMP Deviations

    American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding due to lack of stability data and controls supporting expiration dates.

    Product
    Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0534-2018·2018-02-28

    Verapamil HCl USP Recalled for Missing Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Verapamil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.

    Product
    Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2018·2018-02-28

    FDA Recalls Diclofenac Sodium USP Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Diclofenac Sodium USP for prescription compounding because it lacks stability data to support expiration dates.

    Product
    Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Levothyroxine Sodium Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling specific lots of Levothyroxine Sodium USP for prescription compounding due to a lack of stability data and controls to support the assigned expiration dates.

    Product
    Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide

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