Drug Recalls


On May 3, 2018 -

AuroMedics Pharma LLC is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 grams*/ Single-Dose vial, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.

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



On April 11, 2018 -

Premier Pharmacy Labs issues voluntary nationwide recall of specific sterile injectable products lots due to a potential lack of sterility assurance.

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



On March 5, 2018 -

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots.  This impurity has not yet been identified.

An elevated impurity has the potential to decrease effectiveness of the product in patients. To date, Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.

Methylprednisolone Sodium Succinate for Injection, USP is an anti-inflammatory glucocorticoid indicated for a number of conditions, including but not limited to: allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, miscellaneous (trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy), neoplastic diseases, nervous system, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders. The product is supplied in 5 ml, 10 ml, and 30 ml glass tubular vials. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide from April 2017 through February 2018.

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

 

 

 



On January 29, 2018 -

Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

 

 

 

 

Risk Statement: The product potentially could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment. Kareway Products, Inc has not received any reports of adverse events related to this recall.

 

 

 

 

 

 

The product is used as eye wash to clean, refresh, soothe eyes for daily use or emergency eye cleansing by flushing foreign material. It is packaged in 4 fluid ounce (118 ml) bottles. The affected Gericare Eye Wash, Sterile Eye Irrigation Solution lots include the following Lot#86041601 and expiration date of 09/2019. The product can be identified by UPC 3-57896-18604-3. The product was distributed Nationwide to wholesale businesses.

 

 

 

 

 

 

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

 

 



On January 26, 2018 -

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.

 

 

 

 

Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.

 

 

 

 

 

 

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

 

 

 

 

 

 

 



On January 19, 2018 -

Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

 

 

 

 

Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who have recently undergone cardiac bypass graft surgery. Patients may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, bleeding, ulceration, or perforation of the stomach or the intestines. The populations most at risk are: children, pregnant women, nursing mothers, and surgical patients. Magno-Humphries Laboratories, Inc., has not received any reports of adverse events related to this recall to date.

 

 

 

 

 

 

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

 

 

 

 

 



On January 16, 2018 -

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

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



On January 10, 2018 -

International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

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



On December 19, 2017 -

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial.  This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass.

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



On November 30, 2017 -

Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.

The use of impacted Alcohol Prep Pads could result in adverse events such as infections. To date, Simple Diagnostics has not received any reports of adverse events associated with use of these Sterile alcohol prep pads.

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.