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[2/10/2016] The U.S. Food and Drug Administration is alerting compounding pharmacies of the voluntary recall of certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in compounding of various oral liquid drug products, due to the presence of yeast ( Candida galli ). The SyrSpend SF lots are: 15I21-U01-026920 15J26-U05-027457 15J26-U05-027473 15I21-U01-027370 15J19-U05-027406 The SyrSpend SF Grape lots are: 15G29-U03-025975 15A05-U03-022765 15A05-U06-023277 If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary. FDA recommends that compounders not use the...

[2/16/2016] The U.S. Food and Drug Administration is alerting Health care professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride , 1 mL syringe, CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals, in Noblesville, Indiana, because the product is super-potent. Pharmakon initiated the voluntary recall on February 11, 2016, after receiving laboratory results showing the product was super-potent.   Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death . Health care professionals should immediately check their medical supplies, quarantine the recalled product from Pharmakon , and not administer them to patients.   The recalled product was made on Februar...

[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...

[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...

[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...

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’...

[8/31/2018] The Food and Drug Administration is alerting consumers and Health care professionals to a voluntary recall of certain lots of HelloLife (Grand Rapids, Michigan) drug products, Neuroveen, Respitrol, Thyroveev and Compulsin. The products labeled as homeopathic are being recall ed due to microbial contamination.   According to HelloLife, Neuroveen was tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia . Compulsin was tested and found to be contaminated with Burkholderia cepacia . Respitrol and Thyroveev are still pending bacterial identification. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening t...

[9/7/2018] The Food and Drug Administration is alerting consumers and Health care professionals to a voluntary recall of all water- and alcohol-based Beaumont Bio Med Inc. (Grand Rapids, Michigan) drug products . These products , labeled as homeopathic, are being recall ed due to microbial contamination at the manufacturing facility.  Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. These products were manufactured at the King Bio, Inc. facility in Asheville, North Carolina. Previously, FDA alerted consumers of HelloLife’s voluntary recall of drug products labeled as homeopathic, also manufactured by King Bio. Health care pro...

[9/14/2018] The Food and Drug Administration is alerting consumers and Health care professionals about a voluntary recall of certain lots (1138, 1139, 1146, and 1160) of NeoRelief distributed by BioLyte Laboratories (Grand Rapids, Michigan). NeoRelief is labeled as a homeopathic topical for the temporary relief of occasional muscle cramps, restlessness and twitching and is being recall ed due to microbial contamination at the active ingredient manufacturing facility. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Some of NeoRelief’s active ingredients were manufactured at a King Bio Inc. facility in Asheville, North Carolina. Previously, FDA alerted consumers of HelloLife’s voluntary recall of drug products l...

[10/11/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots with expiration dates from October 2018 to July 2022 of Sprayology’s water-based homeopathic product line for human use. These products are labeled as a homeopathic and are being recall ed due to microbial contamination at the King Bio Inc. manufacturing facility in Asheville, North Carolina. Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Previously, FDA alerted consumers to four other voluntary recall s related to King Bio’s recall : Health care professionals and patients should report any adverse events associated with Sprayology's products to the FDA’s MedWatch Adverse Event Reporting pr...

[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...

Update [3/29/19] FDA is alerting health care professionals and patients of McDaniel Life-Line’s voluntarily recall of all lots of Life-Line Water. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa . [2/12/19] FDA is alerting patient s of a voluntary recall of all lots of unapproved Indian Herb made and distributed by McDaniel Life-Line, Felt, Oklahoma, because it was manufactured under poor conditions. The agency has concerns this product’s ingredients may burn through the skin, causing serious patient injury. FDA recommends patients who have Indian Herb stop using it immediately and discard it. Using the product could result in a disfiguring chemical amputation, which could require plastic surgery. FDA also recommends patients not use McDaniel’s L...

[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 ...

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...

[4/26/2022] FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections. APS Pharmacy, located in Palm Harbor, Florida, which compounds drugs intended for human use and drugs intended for animal (veterinary) use, initiated the voluntary nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to all patients and animal owners who received the recall ed drugs , and they are contacting all customers via telephone calls and emails as part of their recall strategy. ...