Furosemide, Sodium Chloride Injection Recalled for Visible Precipitate

Stay up to date on the latest product recalls issued by the US Food and Drug Administration (FDA) this past week.

Furosemide 100 mg in 0.9% Sodium Chloride Recalled by SCA Pharmaceuticals for Precipitate

For visible particulate matter believed to be furosemide precipitate, SCA Pharmaceuticals is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag.

One customer complaint over the presence of precipitate has been recorded to SCA Pharmaceuticals. However, no adverse events have been reported to date.

Therapeutic failures due to dosages that may be lower can occur. Blockage of blood vessels and/or catheter occlusions can also occur with intravenous administration.

Three hospitals in Connecticut, Virginia and Washington, DC were distributed the lots associated with the recall.

To view the 7 lots being recalled, check out the US Food and Drug Administration’s (FDA’s) statement.

Montelukast Tablets USP, 10mg 30Ct. Recalled by Camber Pharmaceuticals for Product/Label Mix-Up

One single lot of Montelukast Sodium Tablets, USP 10mg, (lot# MON17384 Exp. 12/31/2019), is being recalled by Camber Pharmaceuticals due to a complaint of a sealed bottle labeled as Montelukast 10mg 30ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg.

Inadvertent consumption of Losartan may result in renal dysfunction, hyperkalemia, and hypotension. Fetal toxicity and risk of fetal morbidity is also associated with Losartan.

The recalled product is in 30ct bottles labeled NDC is 31722-726-30 that has been distributed to distributed nationwide to wholesalers, distributors, and retailers.

For more information on this recall, check out the US Food and Drug Administration’s (FDA’s) statement.

Homeopathic Aqueous/Alcohol-Based Medicines Recalled by Beaumont Bio Med for Possible Microbial Contamination

Due to possible microbial contamination, Beaumont Bio Med's entire aqueous/alcohol-based product line for human use, within expiry, is being recalled. King Bio, the contract manufacturer, has also recalled all its products due to possible microbial contamination.

While possible microbial contamination can result in infections that may require medical intervention and could be potentially life threatening to certain individuals, the company has not yet received any reports of adverse events related to this recall.

To see the full list of products being recalled, check out the US Food and Drug Administration’s (FDA’s) statement.

Tri-Flo Subglottic Suction System Recalled by Vyaire Medical for Risk of Device Breakage

The Tri-Flo Subglottic Suction System is being recalled by Vyaire Medical, Inc in a Class I recall for risk of the distal soft tip of the catheter breaking off and entering the patient's lungs.

Choking, wheezing, additional surgery to remove the tip from the patient's lungs, irritation and reddening of the skin (erythema) of the airways, infections, or death include serious adverse health consequences that may occur.

Approximately 2,150 units were distributed nationwide from January 23, 2018 to May 23, 2018.

For more information on this recall, check out the US Food and Drug Administration’s (FDA’s) statement.