Drug Recalls


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.



On August 31, 2017 -

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.



In the event that impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur. The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated.  No batches of product have been identified as containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.



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

 



On August 30, 2017 -

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.



In the event the particulate is administered to a patient, it may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

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

 



On August 22, 2017 -

Centurion Labs is voluntarily recalling, as a precautionary measure, one lot of Ninjacof (Lot# 200N1601) and one lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.

Use of a product that may contain B. cepacia, could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life threatening in the at-risk patient population.

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



On August 18, 2017 -

Bella Pharmaceuticals voluntarily recalled all lots of unexpired sterile drug products due to lack of sterility assurance.  The recalled products were distributed to health care facilities nationwide. 

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.

The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. 

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



On August 17, 2017 -

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance. Atlantic Pharmacy and Compounding became aware of this issue during an FDA (Food and Drug Administration) inspection of the pharmacy. 
 
Risk Statement: The compounded injectable prescription medications potentially could result in adverse effects.  To date, Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding has not received any reports of adverse events related to this recall.

The compounded injectable prescription is packaged in sterile vials for injection.

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is notifying its patients by U.S. Mail and is requesting that all unexpired lots of compounded injectable prescription medications be destroyed immediately upon receipt of the notification. Patients that have compounded injectable prescription medications which are being recalled should stop using the compounded injectable prescription medications and discard any remaining unused medication.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information about the recall, please see the FDA website.



On August 18, 2017 -

Amneal Pharmaceuticals, LLC. is voluntarily recalled 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL (NDC 65162-687-84). The NDC can be found on the label.

This drug was recalled because of a defect with the dropper used to take the drug. This could result in taking the wrong dose of the drug.

Lorazepam Oral Concentrate, USP 2mg/mL, NDC 65162-687-84

Lot Number, Expiration Date 
06876016A, 08/2018
06876017A, 08/2018
06876018A, 08/2018
06876019A, 09/2018
06876020A, 09/2018
06876021A, 09/2018
06876022A, 09/2018
06876023A, 11/2018
06876024A, 12/2018
06876025A, 12/2018
06877001A, 02/2019
06877002A, 02/2019
06877003A, 03/2019

If you think this recall affects you, please call the pharmacy that gave you the drug or contact your health care provider. Please call Amneal Pharmaceuticals if you have questions. Their phone number is 631-952-0214 x338. They can be reached Monday – Friday between the hours of 9 a.m. – 5 p.m. EST. For more information about this recall, please see the FDA website.  
 



On August 10, 2017 -

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.

The distribution firms are committed to patient safety and are partnering with the Food and Drug Administration to notify customers who may be in possession of liquid products manufactured by PharmaTech LLC.

Please see the FDA website for more information about this drug recall.



On August 10, 2017 -

International Laboratories, LLC voluntarily recalled one (1) lot of the drug listed below due to mislabeling.

 

 

The drug was recalled because a single bottle was labeled Pravastatin Sodium Tablets USP 40 mg, but contained Bupropion Hydrochloride XL 300 mg tablets.

 

 

 

 

Drug NDC and Lot:
Pravastatin Sodium Tablets USP 40 mg 54458-925-16 115698A

 

 

 

 

If you think this recall affects you, please call the pharmacy that gave you the drug and contact your health care provider before taking your next dose.

 

 

 

 

Please call International Laboratories, LLC if you have questions. Their phone number is 727-322-7146. They can be reached Monday – Friday between the hours of 8 a.m. – 5 p.m.

 

 

 

 

See the FDA website for more information about this recall.

 

 



On August 4, 2017 -

Rugby Laboratories voluntarily recalled Diocto Liquid and Diocto Syrup (docusate sodium solutions) manufactured by PharmaTech, LLC of Davie, FL due to a risk of product contamination with Burkholderia cepacia. This recall includes all lots of the following drugs.

Diocto Liquid 50 mg/5 mL
NDC 0536-0590-85

Diocto Syrup 60mg/15mL
NDC 0536-1001-85

Stop using this drug if you think this recall affects you. Please call the pharmacy that gave you the drug.

If you have questions, please call Rugby's Customer Support Department. They can be reached at 1-800-645-2158. You can reach them from 8 a.m. to 8 p.m. Eastern time, Monday through Friday. See the FDA website for more information about this recall.



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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.