Medication Monitor

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Generic Name (Trade Name—Company)
  • August 29, 2018

    Accord Healthcare is voluntarily recalling one lot (#PW05264 – 46632 bottles, NDC 16729-182-01) of hydrochlorothiazide tablets 12.5 mg to the consumer level.

    A 100-count bottle was found to contain 100 spironolactone tablets 25 mg. Since the individual lot of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

    Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of hydrochlorothiazide tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.

    More information is available on FDA's website.

  • August 29, 2018

    Product Quest Manufacturing is voluntarily recalling lot #173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level.

    The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

    More information is available here.

  • August 20, 2018

    FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API because of inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015.

    This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism.

    FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound drugs for patient use. Risks associated with over- or under- treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

    FDA placed Sichuan Friendly on import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection.

    However, FDA confirmed Sichuan Friendly’s thyroid API remains in the U.S. supply chain. Sichuan Friendly API may be repackaged and/or relabeled before it is further distributed, and not all of the repackaged/relabeled API identifies Sichuan Friendly as the original API manufacturer. Therefore, manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it. Sichuan Friendly’s products may be labeled as “Thyroid Powder” or “Thyroid Powder USP.”  

    In addition, manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products. If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA’s regional offices.

    FDA recommends patients talk to their health professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA approved.

  • August 20, 2018

    FDA has updated the prescribing information for pembrolizumab and atezolizumab to require use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two different companion diagnostic tests were approved by FDA, one for use with pembrolizumab (Dako PD-L1 IHC 22C3 PharmDx Assay [Dako North America]) and one for use with atezolizumab (Ventana PD-L1 [SP142] Assay (Ventana Medical Systems)].

    The second-line indications in urothelial carcinoma for both drugs remain unchanged.

    The tests used in the trials to determine PD-L1 expression are listed in Section 14 of each drug label.

  • August 20, 2018

    Westminster Pharmaceuticals is voluntarily recalling all lots of levothyroxine and liothyronine thyroid tablets in strengths of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg.

    These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

    To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.

    Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.

    The products subject to recall are packed in 100-count bottles.To best identify the products, see this table.