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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...

[3/30/2016] The U.S. Food and Drug Administration (FDA) is alerting health care professionals, patients, and pet owners of a voluntary recall of all unexpired compounded drug products produced and distributed by Reliable Drug Pharmacy in San Francisco, due to concerns over mislabeled compounded drug products. The recalled products were compounded for human and animal use and were distributed between March 24, 2015, and March 24, 2016. Health care professionals, including veterinarians, patients, and pet owners should immediately check their medical supplies and quarantine any compounded drug products produced by Reliable Drug. Patients and pet owners should contact their health care professional before stopping the medication. The recalled products are labeled as: Reliable Drug or Reliable Compounding Pharmacy. Dur...

[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...

[07/28/2017] The U.S. Food and Drug Administration received adverse event reports on April 5 and June 1, 2017, and conducted follow-up, concerning at least 43 patients who were administered intravitreal (eye) injection s of a drug containing triamcinolone (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, Texas, by physicians affiliated with the Key Whitman Eye Center, and at the Park Central Surgical Center in Dallas, Texas, 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...

[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...

[3/16/18] FDA is alerting consumers of a voluntary recall of Bayer’s Alka-Seltzer Plus product s due to labeling errors . Bayer is voluntarily recall ing Alka-Seltzer Plus® packages that: Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry's Food Stores, Ralphs, King Soopers and Smith's Food and Drug) after February 9, 2018. Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall. Consumers who purchased packages of Alka-Seltzer Plus that are being recalled should stop using the product immediately. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to...

FDA lab confirmed high levels of microbial contamination in company’s Pasta De Lassar Andromaco diaper rash treatment En Español [3/30/2018] The U.S. Food and Drug Administration is alerting consumers of a voluntary recall of a topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment, made by Industria Farmacéutica Andrómaco, Toluca, Mexico, and distributed by MarcasUSA LLC, El Segundo, California. FDA laboratory analysis confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve diaper rash, where irritated skin can become infected. Therefore, consumers and caregivers should not use this product due to possible microbial contamination that may cause infection...

[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...

[7/5/2018] The Food and Drug Administration (FDA) is advising consumers not to use Blissful Remedies kratom product s sold by World Organix LLC, Las Vegas, Nevada. FDA laboratory analysis found that the product s are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas aeruginosa. Blissful Remedies announced a recall on June 30, 2018. FDA is concerned this recall does not include all lot numbers of the affected products. FDA has received reports of adverse events associated with kratom product s. There are no proven medical uses for kratom and the public is strongly discouraged from consuming kratom . Kratom is an inherently addictive product that can cause harm. FDA encourages Health care professionals and ...

[11/8/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots of Puriton Eye Relief Drops, 0.5 oz. (15 ml) bottle. These product s are labeled as a homeopathic and are being recall ed due to non -sterile production conditions at the manufacturing facility. Consumers should stop using this product and contact their physician or Health care provider if they experience any problems that may be related to using this product . Puriton Eye Relief Drops are over-the-counter homeopathic eye drops marketed for the temporary relief of burning and irritation due to eye dryness and eye discomfort due to minor irritations or to exposure to wind or sun. Kadesh, Inc., is voluntarily recalling all non-expired lots of Puriton Eye Relief Drops. The company distributed the product nation...

[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...

[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...

en Español [7/3/2023]  Since April 20, 2022, FDA learned that more than 30 additional consumers have experienced a serious health effect after using unapproved over-the-counter products with “Artri” or “Ortiga” in the product name. Reported harmful effects include sudden weight gain, serious gastrointestinal damage including bleeding and ulceration, increased blood glucose (sugar) levels, adrenal dysfunction, liver toxicity, and other serious conditions. Some of these problems can be life threatening or fatal. FDA continues to warn consumers to avoid use of these products that contain potentially harmful hidden ingredients. In addition, the agency issued a warning letter and an import alert for certain products. [10/28/2022]  In support of public safety, and because some of these products may still be av...

[5/1/2023] FDA is warning consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy. These product s are inhalants and primarily contain ammonia. Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction. FDA has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using the Nose Slap or Soul Slap product s. These product s may have been purchase d online through the Nose Slap website. On April 24, 2023, FDA issued a warning letter to Nose Slap LLC for marketing these unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act. These product s have not been demonstrated to be safe or eff...