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[03/09/2016] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance.   Health care professionals and consumers should immediately check their medical supplies, quarantine any drug products labeled as sterile from I.V. Specialty, and not administer them to patients.  Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards. During FDA’s recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile product ion practices, which raise concerns about I.V. Specialty’s abil...

[4/1/2016] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally.     Health care professionals and patients should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medaus, and not administer them.   During FDA’s recent inspection of Medaus’ facility, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Medaus’ ability to assure the sterility of drug products that it produced. Administration of a non-sterile product, intended to be sterile, may resul...

[08/10/2017] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance.  Health care professionals and patients should immediately check their medical supplies, quarantine any drug products labeled as sterile from Atlantic Pharmacy, and not administer them to patients. Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices...

[04/13/2018]  The U.S. Food and Drug Administration is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds LLC, of Biloxi, Mississippi, due to visible particles in some of the drug vials for injection.    Injection of a drug product containing particulate matter may result in serious and potentially life threatening adverse events, such as infection, allergic reaction, toxicity, or other reactions. Health care professionals should immediately check their medical supplies, quarantine any sterile drug products intended for injection from Coastal Meds, and not administer them to patients. Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper...

[6/29/2018] FDA advises health care professionals not to use MedGyn Products’ Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions . The solution is manufactured by BioDiagnostics International, Brea, California, and distributed by MedGyn Products, Inc., Addison, Illinois. BioDiagnostics notified MedGyn of the recall of all lots of Monsel’s Solution on June 11, 2018. However, MedGyn has not yet notified its customers to remove any distributed drug product from the market. Monsel’s Solution is used to stop bleeding after medical procedures, such as a colposcopy and a biopsy. The solution is sold in a carton containing 12 single application vials and 12 applicators, 8 mL each, NDC 42721-112-08. Health care professional s should immediately check their medical supplies, ...

[11/19/2018] The U.S. Food and Drug Administration is alerting Health care professionals and patients not to use drug product s intended to be sterile that are produced and distributed by Pharm D Solutions LLC, Houston, Texas, due to lack of sterility assurance. Administration of a non- sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Health care professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Health care professionals should also make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards. Patients who have received drug product s produced by Pharm D and...

Compounded drugs were produced under poor sterile product ion practices in an inadequately designed processing room [12/7/2018] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, Florida, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. During FDA’s recent inspection of Promise Pharmacy’s facility, investigators observed insanitary conditions, including poor sterile product ion practices and inadequate design of one of its processing rooms, which raised concerns about the company’s abilit...

[6/21/2019] The U.S. Food and Drug Administration is alerting Health care professional s and patients of a voluntary recall of all unexpired compounded drugs intended to be sterile produced by Infusion Options, Inc. of Brooklyn, N.Y., due to lack of sterility assurance and other significant quality issues . These drugs may pose a safety risk to patients . Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections or death. Health care professionals should immediately check their medical supplies, quarantine any drugs prepared by Infusion Options, and not administer or provide them to patients. FDA urges health care professionals, who obtained products from Infusion Options, to make alternative arrangements to obtain medications from sources that ...

[ 9/08/2020 ] FDA is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.   Atezolizumab in combination with paclitaxel is not approved for use in breast cancer. However, atezolizumab in combination with paclitaxel protein-bound (Abraxane)—a different combination therapy—is currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Continued approval of atezolizuma...

[7/28/2021] FDA is alerting patient s and Health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto ( melphalan flufenamide ) with dexamethasone to treat patient s with multiple myeloma showed an increased risk of death . The trial compared Pepaxto with low-dose dexamethasone to pomalidomide with low-dose dexamethasone in patients with relapsed or refractory (resistant) multiple myeloma following 2-4 lines of prior therapy and in patients who were resistant to lenalidomide in the last line of therapy.   FDA encourages health care professionals to review patients’ progress on Pepaxto and discuss the risks of continued administration with each patient in the context of other treatments. Patients currently receiving Pepaxto should also discuss with their health care professional the...

[9/29/2021] Update: FDA is alerting veterinarians and animal owners/caretakers not to use compounded products intended to be sterile from Greenpark Compounding Pharmacy. Animal owners/caretakers who have received compounded drugs produced by Greenpark Compounding Pharmacy and have concerns should contact their veterinarian as appropriate. Veterinarians and animal owners/caretakers can report adverse events or side effects related to the use of these products. Please visit How to Report Animal Drug and Device Side Effects and Product Problems for more information. [9/17/2021] FDA is alerting patients and health care professionals not to use compounded products intended to be sterile, produced and distributed nationwide by Prescription Labs Inc. doing business as Greenpark Compounding Pharmacy, Houston, Texas, due to l...

[5/25/2022] FDA is alerting customers of North American Custom Laboratories LLC, doing business as FarmaKeio Superior Custom Compounding’s voluntary recall, initiated on April 5, 2022, of unexpired drug products that are intended to be sterile. This recall includes the products FDA recommended the company voluntarily recall in March 2022. The company emailed recall letters to all patients who received the recalled drug products. Additional information regarding this recall can be found on FDA’s Enforcement Report. [3/30/2022] FDA is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom Laboratories LLC, FarmaKeio Superior Custom Compounding, Richardson, TX, due to a lack of sterility assurance. Administration of a non-sterile drug intended to be st...