Drug Recalls

On September 21, 2020 -

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company in Minneapolis, due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. This recall is to the retail level. FDA urges patients to continue using the inhaler they have on hand.

The albuterol inhaler delivers medication into the body through the airway and lungs, where it opens the airways to treat asthma and other conditions, such as chronic obstructive pulmonary disease (COPD). Patients could face health risks if their rescue albuterol inhaler malfunctions and does not relieve symptoms in an emergency situation. FDA advises patients to:

  • immediately seek emergency care if needed;

  • use their Perrigo inhaler they have on hand, as needed and as directed by a doctor;

  • have extra inhalers or an alternative treatment available in case of malfunction, as some of these recalled inhalers stop working after several uses; and

  • contact their health care professional or pharmacist with questions.

FDA reminds health care professionals and patients that albuterol inhalers are available through additional manufacturers.

For more information about this recall, please visit the FDA website.



On September 3, 2020 -

RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency

​RLC Labs is recalling a total of 483 lots of Nature-Throid and WP Thyroid in all strengths because testing of samples from six lots by FDA found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine (T4).

Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid or WP Thyroid, may experience a variety of signs and symptoms of hypothyroidism (underactive thyroid) including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.

There is reasonable risk of serious injury in newborn infants, pregnant women and in elderly patients with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development, cardiac pain, palpitations or cardiac arrhythmia.

For more information about this recall, please visit the FDA website.



On August 5, 2020 -

Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing.

The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could eventually lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed.

For more information about this recall, please visit the FDA website.



On March 4, 2020 -

Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels. The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots.



On December 23, 2019, Hikma voluntarily initiated a recall of this product to the direct customer level. In coordination with the U.S. Food and Drug Administration (FDA), Hikma is extending the recall to the medical facility and retail levels.



Administration of the affected product could potentially result in the deposition of particulates in the lungs of patients, which could result in multiple pulmonary microemboli with subsequent acute respiratory distress for patients receiving the drug intravenously.



For more information about this recall, please visit the FDA website.



On February 20, 2020 -

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and is packaged in amber plastic bottles with an inner seal and a white child proof closure, and each bottle contains 237 mL. The reason for the recall is that product from these two lots of Phenytoin Oral Suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. 



For more information about this recall, please visit the FDA website.



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Drug Recall ProcessThe U.S. Food and Drug Administration (FDA) has jurisdiction over food, drugs, cosmetics, medical devices and other products and services as a monitor over product recalls. In most cases recalls are done voluntarily by the manufacturer or the distributor of the product. In some cases, a company will discover that one of its products is defective and will recall it. In other cases, the FDA will notify a company that one of its products is defective and will suggest or request a recall.

The FDA has guidelines for companies to follow in recalling defective products. These guidelines explain that the FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. The guidelines categorize all recalls into one of the three classes according to the level of hazard involved.

 

 

 

  • Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
  • Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
  • Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violates FDA regulations.


Navitus Health Solutions LLC is a transparent Pharmacy Benefit Manager for a variety of health care plans. Navitus is not owned or operated by an entity related to the pharmaceutical manufacturing industry. Navitus is also not responsible for the manufacture, distribution or recall of any medication. This notification is meant solely to provide information to our clients, members and policyholders, regarding the various recalls of medications by the FDA. Navitus assumes no liability for the information contained in these notifications.

 

This plan, Navitus MedicareRx (PDP), is offered by Navitus Health Solutions and underwritten by Dean Health Insurance, Inc., A Federally-Qualified Medicare Contracting Prescription Drug Plan.