In this week’s installment of the DrugNews FDA Recall & Warning Recap, we look at eight actions taken by the agency over the past week. These ranged from simple food-based allergies to bacterial presence to lead contamination in foods.
Here is more information on the most recent recalls and what consumers should know.
FDA Food Recalls
The agency reported Oriental Packing Company issued a recall of its Blue Mountain, Jamaica Choice and other blended seasoning curry products due to lead contamination.
Rabbit Creek Products announced a recall of bread, muffin and brownie mixes from their Rabbit Creek, Impressions Everlasting and other brands due to the potential presence of escherichia coli O121.
The FDA reported that Ton Shen Health issued a recall of its Life Rising DHZC-2 Chinese Herbal Supplement tablets also due to elevated amounts of lead.
Grassfields Cheese Company announced a recall of its Gouda, Onion ‘n Garlic, Country Dill, Leyden, Edam, Lamont Cheddar, Fait Gras and Polkton Corners brand cheeses due to the potential presence of Shiga toxin-producing E. coli (STEC).
Finally, Beyond Better Foods, LLC recalled its Enlightened Ice Cream brands of Mint Chocolate Chip and Peanut Butter Chocolate Chip due to the undisclosed presence of peanuts.
FDA Medical Product Recalls
PharmaTech, which produces over-the-counter vitamin and nutritional supplement products, notified the FDA of a voluntary recall of its entire line of liquid products sold from October 20, 2015 through July 15, 2016 due to the potential risk of Burkholderia cepacia contamination, which may cause serious infections.
The agency announced a recall affecting the Roadrunner Uniglide Hydrophilic Wire Guide, which is used in the delivery of percutaneous catheters into the peripheral vasculature. DSM Biomedical, who supplies Cook Medical with the hydrophilic coating for the devices, recalled certain lots of material due to possible contamination by glass particles. Around 8,750 devices are affected.
Finally, Pfizer subsidiary Hospira issued a recall of lot 59-064- DK of its 0.25% Bupivacaine Hydrochloride Injection with drug code 0409-1159-02, expiration date November 1, 2017, distributed to wholesalers and hospitals between December 2015 and January 2016. The product is used for local or regional analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
The recall was issued due to the presence of a foreign matter contaminant that may cause local swelling, irritation or blockage of blood vessels or tissue, and/or allergic reactions.
Keep up with DrugNews for more of the latest information on food and drug warnings, studies and recalls.
FDA. Recalls, Market Withdrawals & Safety Alerts. (August 17, 2016). Retrieved from www.fda.gov
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.
The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.