Drug Recalls


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.



On November 24, 2017 -

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall).

This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

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

 



On November 16, 2017 -

Greenstone LLC, a wholly owned subsidiary of Pfizer Inc., is  voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent.

 

 

 

 

Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression.

 

 

 

 

 

 

The use of the impacted super potent product when used as labeled has a low probability of being associated with adverse events of limited severity such as lethargy, skin flush, and drowsiness. Serious adverse events such as coma and respiratory depression areimprobable. If a patient was to receive a sub potent tablet, symptoms may not be controlled. To date, there have been no reports of adverse events related to this recall.

 

 

 

 

 

 

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

 

 



On September 1, 2017 -

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. 

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The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered. While the lower than expected potency results affected only certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose, in an abundance of caution, PharMEDium is recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose. To date, PharMEDium has received four reports of product complaints related to the products.

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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.