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FDA Alerts

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

United Trading Inc of Des Plaines, IL, is recalling its 7 ounce and 14 ounce packages of “Gazab Green Raisins (Chinese)”, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products. 8/17/2017 4:53:00 PM

Seven Sundays LLC of Minneapolis, MN is recalling their Vanilla Cherry Pecan Muesli 12 oz. pouches because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products. 8/16/2017 1:38:00 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

St Louis-based Dierbergs Markets is recalling two Deli Products with multiple use by dates in all 25 retail stores due to the presence of undeclared fish (bonito, cod), undeclared lobster, crab, and shrimp in scampi butter and undeclared soy and wheat in cabernet grille butter. People who have allergies to fish, lobster, crab, shrimp, soy, or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. 8/15/2017 11:03:00 AM

Litehouse Inc. is voluntarily recalling a limited quantity of its OPA by Litehouse Ranch because it may contain undeclared eggs. The Food and Drug Administration has been made aware of this recall which is limited to one production day from a single manufacturing location. 8/14/2017 8:52:00 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

Schnucks Bakery, a St. Louis, Mo. establishment, is issuing an allergy alert on 13 German Chocolate Cakes labeled as “Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow” that contain pecans that are not listed on the ingredient label. Those with an allergy or severe sensitivity to pecans run the risk of a serious or life-threatening allergic reaction if they consume this product. 8/9/2017 2:15:00 PM

Taylor Farms Retail, Inc. in Salinas is conducting a limited recall of 293 cases of Taylor Farms Creamy Homestyle Coleslaw Kits due to an undeclared milk allergen. Milk is an ingredient in the dressing packet included in the salad kit. This recall is limited to one production day from a single location which distributes to Raley’s in California and Savemart in California. The recall did not apply to any other Taylor Farms products. 8/8/2017 6:46:00 PM

Agroson’s LLC of Bronx, NY is recalling 2,483 boxes of Maradol Papaya Cavi Brand, grown and packed by Carica de Campeche, as a precaution because other brands that also buy from this farm have been tested positive for Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. 8/5/2017 2:24:00 AM

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

Amrita Health Foods is recalling a limited number of Amrita Bars because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. No confirmed illnesses have been reported to public health authorities to date. 8/3/2017 12:29:00 AM

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. 8/2/2017 7:17:00 PM

The AMPT Life, LLC is voluntarily recalling all lots of AMPT Coffee to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED). AMPT Coffee also contains undeclared milk. 8/2/2017 2:23:00 AM

Sacramento, California, Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil. 7/31/2017 2:39:00 PM

ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. 7/28/2017 10:03:00 PM

Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg. 7/27/2017 4:05:00 PM

Please find more information about the Outbreak of Salmonellosis Linked to Papaya here: 7/25/2017 11:35:00 PM

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. To date, Cantrell has not received any reports of adverse events. 7/25/2017 6:01:00 PM

Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall. 7/25/2017 2:16:00 AM

Charlotte, NC, Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, [1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry], distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED). 7/21/2017 7:40:00 PM

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