August 23, 2017
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 […]
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August 21, 2017
There’s perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health. There are few more common decisions that […]
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August 18, 2017
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.
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August 18, 2017
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.
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August 17, 2017
As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection.
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August 17, 2017
The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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August 17, 2017
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.
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August 16, 2017
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. Read The Complete Story!
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August 16, 2017
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.
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August 15, 2017
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 […]
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August 15, 2017
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, […]
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August 14, 2017
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. Read The Complete Story!
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August 11, 2017
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.
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August 11, 2017
The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for […]
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August 10, 2017
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.
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August 10, 2017
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.
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August 9, 2017
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 […]
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August 8, 2017
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 […]
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August 8, 2017
The Comfy Cow is recalling pints of Banana Puddin Y’all, Chocolate Squared2, Cookies and Cream, Cow Trax, Double Fold Vanilla, Georgia Butter Pecan, Intense Dark Chocolate, Salted Caramel, Strawberry Fields Forever due to a potential contamination of E. coli. E. coli bacteria can cause diarrhea and dehydration. Most people who are infected recover, but the […]
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