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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...

[5/6/2016] FDA is alerting health care professionals of a voluntary recall of all non-expired drug compounded products intended to be sterile and distributed nationwide by Pharmakon Pharmaceuticals, Inc., of Noblesville, Indiana, due to a lack of sterility assurance and other quality issues. These compounded products are used for a variety of indications and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc., name, address and expiration date. The products were distributed nationwide to hospitals from March 4, 2016, to April 15, 2016. Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Pharmakon, and not administer them to patients. Administration of a non-s...

[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...

Update [7/31/2018] FDA is alerting Health care professionals and patients, as well as veterinarians and animal owners, of Ranier’s Rx Laboratory’s voluntary recall of unexpired compounded drug products intended to be sterile . The recall ed products were dispensed between January 17, 2018, and July 10, 2018. See Ranier’s notification for additional information. FDA alerts health care professionals, patients, veterinarians and animal owners not to use sterile drug products from Ranier’s Compounding Laboratory [7/10/2018] The U.S. Food and Drug Administration is alerting health care professionals and patients, as well as veterinarians and animal owners, not to use human and animaldrug products intended to be sterile that are produced and distributed by Ranier’s Compounding Laboratory, also doing business as Ranier’...

[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...

Agency is aware of adverse events related to compounded glutathione injection [2/1/2019] FDA is warning compound ers not to use glutathione -L-reduced powder distributed by Letco Medical, Decatur, Alabama, to compound sterile injectable drugs for patients. Based on reported adverse events, the agency has concerns with use of the Letco distributed glutathione to compound injectable drugs due to potential endotoxins. Letco supplied this glutathione powder to about 100 compounders in 30 states. FDA urges compounders that use glutathione to make sterile injectable drugs to ensure the glutathione powder is appropriate for compounding sterile drugs, including checking with their supplier. FDA is aware of seven patients who experienced various adverse events ranging from nausea and vomiting to difficulty breathing,...

Update [9/9/2019] FDA is alerting patients and Health care professionals of Pacifico National Inc.’s, dba AmEx Pharmacy, voluntary recall of all unexpired drugs . AmEx Pharmacy has not been operational since July 27, 2019. Following FDA’s formal recall request on Aug. 27, 2019, AmEx Pharmacy agreed to recall all unexpired drugs intended to be sterile an continue to cease operations. FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy [6/28/2019] FDA is warning patients and health care professionals not to use products intended to be sterile produced by Pacifico National Inc., doing business as AmEx Pharmacy, Melbourne, Florida, due to a lack of sterility assurance. These drugs may pose a safety risk to patients. Administration of a non...

[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...