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Friday, June 16, 2017

RECALLS

06/15/2017 05:43 PM EDT
NEW ENGLAND NATURAL BAKERS of Greenfield MA, is issuing a voluntary recall, the company has been notified by an ingredient supplier that an ingredient used in these products has the potential to be contaminated with Listeria monocytogenes.
06/16/2017 07:26 AM EDT
Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
06/15/2017 05:53 PM EDT
Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 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 compounded NitroGlycerin Injection which would lead to a lower dose being administered.
06/15/2017 02:09 PM EDT
Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the CONSUMER/USER level.
06/16/2017 09:15 AM EDT
NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is expanding the voluntary recall of Ellyndale® Nutty Infusions™ Roasted Cashew Butter – Product Code E0540, Lot# 2125155, and Ginger Wasabi Cashew Butter -- Product Code E0541, Lot# 2124118, to include Roasted Almond Butter – Product Code E0545, Lot# 2124119, and Mango Chili Cashew Butter – Product Code E0542, Lot# 2125156. An FDA follow-up inspection of the Nutty Infusions supplier’s facility revealed these lots 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.
06/16/2017 09:43 AM EDT
Willis Ocean Inc., Brooklyn, NY, is recalling its “the duck” brand “frozen steamed scomber fish”, because the product was found to be uneviscerated. The steamed scomber fish were distributed nationwide through retail stores.
Channel Fish Processing Co., Inc. Recalls Siluriformes Fish Products Due to Misbranding and Undeclared Allergens
Channel Fish Processing Co., Inc, a Boston, Mass. establishment, is recalling approximately 840 pounds of breaded Swai products due to misbranding and undeclared allergens.
Embutidos Fanguito, Inc. Recalls Pork Products Due to Mislabeling, Misbranding, and Undeclared Allergens
Embutidos Fanguito, Inc., a Miami, Fla. establishment, is recalling approximately 454 pounds of pork products due to mislabeling, misbranding and undeclared allergens.

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