Drug Recalls

On October 5, 2020 -

​Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

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



On September 23, 2020 -

Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspensio), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.  To date, SUN PHARMA has not received any reports of adverse events related to this recall.

RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.  RIOMET ER™, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle.  Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup.

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



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.



On January 10, 2020 -

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.

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



On December 17, 2019 -

Glenmark Pharmaceutical Inc., USA (“Glenmark”) announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.

The recalled lots of Ranitidine Tablets 150 mg and 300 mg, which are listed in Attachment B, are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall.

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

 

 



On November 15, 2019 -

Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA.

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



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Drug Recall Process: The 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.