PharmaTech LLC Issues Voluntary Nationwide Recall Due to Potential Risk of Product Contamination

PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential 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.

Update: Gel Spice, Inc. Issues Expanded Recall of Ground Tumeric Powder Due to Elevated Lead Levels

Gel Spice, Inc. is expanding its recall of ground turmeric powder to include additional brands because of elevated lead levels. Lead can accumulate in the body over time. Too much can cause health problems, including delayed mental and physical development and learning deficiencies. Pregnant women, infants and young children especially should avoid exposure to lead.

Beyond Better Foods, LLC Issues Allergy Alert On Undeclared Peanuts In Mislabeled Peanut Butter Chocolate Chip Ice Cream

Beyond Better Foods, LLC is recalling select cases from a single production run of Enlightened brand Peanut Butter Chocolate Chip ice cream because they may have been packaged in Mint Chocolate Chip ice cream containers and thus contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Hospira Issues a Voluntary Nationwide Recall For One Lot Of 0.25% Bupivacaine Hydrochloride Injection, USP Due to The Presence Of Particulate Matter Within a Single Vial

Lake Forest, IL – Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. The issue was identified through a confirmed complaint.

FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.

JML Ingredients Recalls IQF Cut Green Beans Because Of Possible Health Risk

JML Ingredients, Inc. of East Petersburg, PA is recalling IQF Cut Green Beans, because it has 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.

Kratom seized in California by US Marshals Service

The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.