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FDA Alerts

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen. People who have an allergy or severe sensitivity to coconut run the risk of a serious or life-threatening allergic reaction if they consume this product. 9/14/2017 3:51:00 PM

On August 2, 2017, OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. 9/13/2017 1:10:00 AM

Cherry Valley Marketplace, West Hempstead, NY, is recalling its 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES and CHERRY VALLEY CHOCOLATE CUPCAKES because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product. 9/12/2017 11:01:00 PM

Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. 9/12/2017 7:20:00 PM

Bravo Produce Inc de San Ysidro, está retirando Maradol Papaya, cultivadas por Productores y Exportadores de Carica Papaya de Tecoman y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V., como manera preventiva, debido a que dicho producto ha probado positivo para Salmonella, es de suma importancia mencionar que dicha bacteria puede afectar a niños, ancianos y personas con sistemas inmunológicos débiles. Los síntomas a experimentar son fiebre, diarrea, náusea, vómito y dolor abdominal. En raras circunstancias, la infección por Salmonella puede resultar en el organismo entrando en el torrente sanguíneo y la producción de enfermedades graves, como las infecciones arteriales (es decir, los aneurismas infectados), endocarditis y artritis. 9/12/2017 3:56:00 PM

Coborn's, Inc. is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy and egg) as a result of an update to the ingredient profile from the manufacturer of the base. People who have an allergy or severe sensitivity to Milk, Soy, and/or Eggs run the risk of serious or life-threatening allergic reaction if they consume these products. 9/11/2017 3:53:00 PM

Bravo Produce Inc. of San Ysidro, is withdrawing Maradol Papaya, grown by Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR of RL and packed by Frutas Selectas de Tijuana, S. de RL de CV, as a preventive measure, because the product has tested positive for Salmonella by exams done by FDA. It is extremely important to mention that this bacterium can affect children, elderly and people with weak immune systems. Symptoms are fever, diarrhea, nausea, vomiting and abdominal pain. 9/10/2017 8:14:00 PM

Simply Fresh Foods, Inc. of Buena Park, CA is recalling 272 cases of one specific lot of its 4-4 ounce packages of "San Francisco Seafood Salad Made with Greek Yogurt" bearing a UPC bar code of 47502 19701 because the individual cups inside the carton may be mislabeled as Seafood Salad with Real Mayonnaise and does not declare "milk". The outer carton is correct and has the correct ingredient statement which declares "milk". People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product. 9/8/2017 11:52:00 PM

The assorted muffin four pack may include a banana nut muffin containing walnuts, an allergen not listed on the label. People who have an allergy or sensitivity to nuts should not consume this product. 9/7/2017 5:53:00 PM

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking. 9/7/2017 1:47:00 AM

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered. 9/1/2017 7:15:00 PM

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall. 9/1/2017 2:22:00 PM

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. 8/31/2017 2:05:00 AM

Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall. 8/30/2017 10:53:00 PM

Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling. 8/30/2017 9:20:00 PM

Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase. 8/25/2017 12:58:00 AM

Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. 8/23/2017 2:52:00 PM

Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide. 8/18/2017 7:29:00 PM

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance. Atlantic Pharmacy and Compounding became aware of this issue during an FDA (Food and Drug Administration) inspection of the pharmacy. 8/18/2017 1:34:00 PM

Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. 8/16/2017 10:09:00 AM

GRAND BK CORP. of Maspeth, New York is recalling its 14 ounce packages of "CALIFORNIA ALOHA MIX" because they may contain undeclared tree nuts (Almonds, Walnuts and Cashews). People who have allergies or severe sensitivity to tree nuts (Almonds, Walnuts and Cashews) run the risk of serious or life-threatening allergic reaction if they consume these products. 8/15/2017 9:28:00 PM

Madhava Natural Sweeteners of LONGMONT, CO is recalling its 13.8 oz. box of MMM... Chocolate Chip Cookie Mix because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product. 8/11/2017 8:55:00 PM

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination. 8/10/2017 7:36:00 PM

International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. 8/10/2017 7:22:00 PM

Rugby® Laboratories of Livonia, MI is voluntarily recalling all lots within the expiry of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC of Davie, FL due to a risk of product contamination with Burkholderia cepacia. If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population. 8/3/2017 3:22:00 PM

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