16 recent drug, device recalls

Medical device and drug recalls, whether voluntary or forced by the FDA, ensure patient safety. Here are 16 reported to the FDA in the last two months:

  1. Auromedics Pharma recalls antibiotic after finding glass in vials
    Auromedics Pharma is recalling a lot of its Ampicillin and Sulbactam injection after finding glass particles in the vials.

  2. International Laboratories recalls blood thinner due to package mislabeling
    International Laboratories is recalling a lot of its blood thinner, Clopidogrel, after finding the packaging was mislabeled and some bottles may contain the wrong drug.

  3. Amneal Pharmaceuticals recalls antacid drug due to carcinogen
    Amneal Pharmaceuticals is recalling three lots of its Nizatidine antacid drug after finding potential levels of NDMA above FDA-accepted levels.

  4.  PharMEDium recalls several drugs after failing to ensure sterility
    PharMEDium is recalling more than 50 lots of several different drugs after failing to ensure the drugs were sterile.

  5. AuroMedics Pharma recalls antibiotic after finding mold
    AuroMedics Pharma is recalling one lot of its Levofloxacin antibiotic after finding it was contaminated with particulate matter it tentatively identified as mold.

  6. Baxter International expanding recall of heart drug after finding particulate matter contamination
    Baxter International is expanding its recall of Nexterone, a drug used to treat heart arrhythmia, after finding the lots were potentially contaminated with an unspecified particulate matter.

  7. Magno-Humphries Laboratories recalls painkiller falsely labeled as a laxative
    Magno-Humphries Laboratories is recalling one lot of its Senna Laxative drug after finding the bottles were mislabeled and actually contained naproxen sodium, a painkiller.

  8. Kareway Products recalling eye drug after finding potential microbial contamination
    Kareway Products is recalling 60,000 units of its Gericare Eye Wash after finding potential microbial contamination.

  9. Primus Pharmaceuticals recalls all lots of osteoarthritis drug due to serious side effects
    Primus Pharmaceuticals is recalling all unexpired lots of its osteoarthritis drug, Limbrel, following a request by the FDA to recall the drug due to rare but serious side effects.

  10. Pfizer recalls blood pressure drug after finding some vials were cracked
    Pfizer is recalling four lots of its blood pressure drug, Labetalol, after finding cracks in the glass on the rims of the vials containing the drug.  

  11. Apace Packaging recalls antiviral drug after product mix-up
    Apace Packaging is recalling one lot of its antiviral drug, acyclovir, after a product mix-up caused some containers to contain torsemide, a fluid retention drug, in addition to acyclovir.

  12. Medtronic recalls brain stent after 10 injuries, 1 death
    Medtronic is recalling 822 of its pipeline flex embolization devices, which are used to treat brain aneurysms, after finding the delivery system can break during surgery and leave fractured pieces inside patients' brain bloodstreams.

  13. Dr. Reddy's recalls vitamin K injections as capsules shatter upon opening
    Dr. Reddy's Laboratories, an India-based pharmaceutical company, is recalling four lots of its phytonadione injections after receiving complaints the containers were breaking and shattering upon opening.

  14. Hikma expands recall of injectable pain drug
    Hikma Pharmaceuticals is expanding a recall of its ketorolac tromethamine injections after finding an undisclosed substance in the drug.

  15. Becton Dickinson recalls infusion pumps linked to 55 injuries, 1 death
    Becton Dickinson is recalling 774,000 of its Alaris System Pump Modules after several system and software errors caused 55 injuries and one death. 

  16. Taro Pharmaceuticals recalls seizure drug
    Taro Pharmaceuticals is recalling two lots of its Phenytoin seizure drug due to an issue with the packaging that may cause under or overdosing.

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