Medication Monitor

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  • August 4, 2017

    ICU Medical, Inc. is voluntarily recalling one lot (#61-841-FW) of 0.9% sodium chloride injection,1000 mL, to the hospital/user level because of a confirmed customer complaint of particulate matter, which was identified as stainless steel within a single flexible container.

    Injection of particulate matter could potentially lead to limited adverse events, such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.

    Prior to administration, health professionals, as instructed in the product labeling, should visually examine the product for particulate matter and discoloration and should discard if a defect is identified. The reported incident was identified prior to use, and there have been no reports of adverse events associated with this issue to date.

    The I.V. solution is indicated for parenteral replenishment of fluid and was distributed nationwide to Hospira customers between April 14, 2016, and February 2, 2017.

  • August 4, 2017

    FDA is alerting health professionals about adverse event reports on April 5 and June 1, 2017, concerning at least 43 patients who were administered intravitreal  injections of a drug containing triamcinolone (a steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients were administered Guardian’s product at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center in Dallas, TX, by physicians affiliated with the Key Whitman Eye Center, and at the Park Central Surgical Center in Dallas, TX, by physicians affiliated with Tylock-George Eye Care.

    According to information received from Park Central, Guardian’s product was injected into the vitreous of the eye at the end of the cataract surgery procedure. The purpose of the injection was to provide postoperative prophylaxis for ocular inflammation and endophthalmitis with the expectation that the patient would not need to use postoperative eye drops.

    Over the course of several months, patients developed various symptoms, including vision impairment (blurred or decreased vision), poor night vision, loss of color perception, photophobia (light sensitivity), glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea. A number of the symptoms were not exhibited until at least 1 month postoperatively.

    During follow-up examinations of the Park Central patients, physicians observed that the patients had diminished visual function involving both visual acuity and visual fields. Optical coherence tomography testing initially showed macular edema (swelling), which was followed in some cases by retinal degeneration. While the symptoms reportedly improved in some patients over the 5-month postoperative period, a number of patients remain with a significant reduction in best-corrected visual acuity and visual fields.

    Compounded drugs have not been reviewed by FDA for safety, effectiveness, and quality. Although compounded drugs can serve an important medical need for certain patients, they also present risks to patients.

  • August 4, 2017

    Apace Packaging is voluntarily recalling one lot (#16710) of cyclobenzaprine HCl tablet 5 mg, 50-count unit dose; and one lot (#16710) of amantadine HCl capsule, 100 mg, 50-count unit dose, to the retail level because of a potential mislabeling. A small number of cartons containing cyclobenzaprine HCl tablets 5 mg UD blister cards may be mislabeled as amantadine HCl capsules 100 mg. The unit-dose blisters inside the carton are correctly labeled as cyclobenzaprine HCl tablet, USP 5 mg.

    Unintentional dosing with cyclobenzaprine HCl may lead to the development of life-threatening serotonin syndrome, which has been reported with cyclobenzaprine HCI when used in combination with other drugs, such as selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.

    The effects of alcohol, barbiturates, and other central nervous system depressants may be enhanced and may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

    Amantadine has a precaution in its prescribing indication about abrupt discontinuation of the medication. A few patients with Parkinson disease who missed doses of amantadine have experienced a parkinsonian crisis (i.e., a sudden marked clinical deterioration). 

    Apace Packaging has not received any reports of adverse events related to this recall.

    Cyclobenzaprine is used for the relief of muscle spasms. Amantadine HCl is used for treatment of Parkinson disease and drug-induced extrapyramidal reactions as well as of various viral-based conditions. Both products are packaged in 50-count hospital unit dose cartons (10 unit doses per card, 5 cards per carton).

  • August 4, 2017

    Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level because they lack sterility assurance. The recalled products were distributed to health care facilities nationwide, except to Connecticut, Hawaii, South Carolina, and Vermont. 

    The affected products include all lots distributed from February 16, 2017, to July 19, 2017, remaining within expiry, and they would be packaged in a syringe or I.V. bag.  Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

    To date, Cantrell has not received any reports of adverse events.

  • August 4, 2017

    Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, 13 g, to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil, which is structurally similar to sildenafil, the active ingredient in Viagra, a prescription drug for erectile dysfunction (ED). The product, which is consumed as an instant coffee, also contains undeclared milk.

    The product is packaged in 13 g red packs, UPC 557205060083, in a box, and each box contains 25 packets. The product was distributed July 2014 through June 2016 nationwide via individuals or internet. No illness has been reported to date.