IMPORTANT INFORMATION: DRUG RECALL
Acyclovir Oral Suspension USP Recalled
On October 28, 2013, Hi-Tech Pharmacal, Co., Inc. issued a recall of Acyclovir Oral Suspension USP, 200 mg/5mL, due to unsatisfactory quality standards during testing.
The recalled lots are as follows:
The NDC affected is 50383-810-16.
Acyclovir is prescribed to treat the symptoms of herpes virus infections, including shingles (herpes zoster), and genital herpes. Acyclovir also treats chickenpox.
Although no adverse health reactions have been associated with this recall, patients in possession of this product should contact the pharmacy or doctor’s office at which it was obtained. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Blood Glucose Meters and TRUEtrack® Blood Glucose Meters Recalled
On January 2, 2014, Nipro Diagnostics, Inc. issued a voluntary recall of TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters which are used for testing blood glucose levels in diabetes patients.
The recalled TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters are displaying glucose results incorrectly. The TRUEbalanceTM and TRUEtrack® Meters are displaying blood glucose results in mmoi/L but should be reading results as mg/dl. Patients may not notice the incorrect unit of measure and may have lower blood glucose levels than perceived. Incorrect blood glucose results may delay medical attention and proper treatment for hypoglycemia and potentially lead to serious injury.
Consumers should check if their TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters have been affected by this recall by visiting www.NiproDiagnostics.com/product-notice or by calling Stericycle toll-free at 1-866-236-4518.
Nipro Diagnostics is offering to replace all TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters at no charge with an expedited return. Consumers with affected TRUEbalanceTM and TRUEtrack® Meters can contact Stericycle toll-free at 1-866-236-4518.
If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
No adverse health reactions have been associated with this recall.
1 gram Cefepime for Injection USP and Dextrose Injection USP Recalled
October 15, 2013, B. Braun Medical has issued a voluntary recall of 1 gram Cefepime for Injection USP and Dextrose Injection USP. B. Braun Medical issued the recall after visible organic particles were found in a reserve sample unit of the medication. The affected lot is H3A744, catalog 3193-11 with an expiration date of January 2015.
The particles found were identified as cotton and metal. If the particles go unnoticed, there is potential for severe injury.
1 gram Cefepime for Injection USP and Dextrose Injection USP is used treat infections such as pheumonia, urinary tract infections, and skin infections
Although, no adverse health reactions have been associated with this recall, patients in possession of this product are asked to return it to the pharmacy or doctor’s office at which it was obtained. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
For product replacement please contact B. Braun’s Customer Support at 1-800-227-2862, Monday through Friday, 8 a.m. to 7 p.m. EST.
Metoclopramide Injection, USP, Recalled
October 1, 2013, Hospira, Inc. has issued a voluntary recall of Metoclopramide Injection, USP. The recall was due to a vial defect where particles were found inside of the vials. The affected lot is 28-104-DK (the lot may be followed by a 1) with an expiration date of October 1, 2014.
The particles found the containers which prompted the recall were identified as glass strands. If the particles go unnoticed, there is potential for severe injury.
Metoclopramide is used to treat gastric esophageal reflux disease. Metoclopramide also treats symptoms of gastroparesis in patients with diabetes.
Prescription Drug Take-Back Day, Presented by the DEA
On April 26, 2014, the Drug Enforcement Administration (DEA) will hold its eighth DEA National Prescription Drug Take-Back Day. This event offers consumers across the nation an opportunity to dispose of old and unused prescription drugs to help prevent these medications for becoming a danger. Prescription Drug Take-Back day will be held at several sites across the country and will be accepting all excess and expired prescriptions, to include controlled substances.
Past DEA Prescription Drug Take-Back Days have collected a combined total of 1,733 tons of disposed of medications. The DEA has coordinated with many states, communities, and local law enforcement for the take-back events.
Every medication, whether prescription or over-the-counter, has its own safe handling instructions and even has an expiration date. It is important to become familiar with and understand these requirements. Some prescriptions require refrigeration. Most can be kept at room temperature. All should be stored in a place where they are not easily accessible which can lead to an accidental overdose, especially by children or even pets.
For more information on local drop off sites of the Take-Back Program and methods for safe at home disposal please visit http://www.awarerx.org/get-local.
FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips Recalled
On November 27, 2013, Abbott issued a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose test strips. The recall is due to the test strips producing incorrect low blood glucose results when testing with FreeStyle® Blood Glucose Meter, FreeStyle® Flash Blood Glucose Meter, and OmniPod® Insulin Management System.
FreeStyle® and FreeStyle Lite® Blood Glucose test strips are used to test blood glucose levels in diabetics.
There have not been any adverse events related to this recall, however; when glucose levels are high and go untreated, patients may not seek the proper treatment for extreme hyperglycemia and which can potentially lead to serious injury.
For replacement test strips, please call Abbott’s diabetes care customer service at (888) 736-9869. Abbott will replace the affected test strips at no cost.
Members using mail order should be aware that Benecard Central Fill did not dispense any of the affected lots.
Effexor ®XR and Venlafaxine HCI Recalled
March 6, 2014, Pfizer Inc. issued a voluntary recall of Effexor XR® 150 mg extended-release capsules (venlafaxine HCl) and Greenstone LLC‘s Venlafaxine HCI 150 mg extended-release capsules. The recall is due to the fact that a pharmacist found one capsule of Tikosyn® in a bottle of Effexor XR. Both medications are being recalled because they use the same packaging system.
Effexor XR and Venlafaxine HCI are both used in the treatment of depression and anxiety disorders. Meanwhile, the drug Tikosyn is used to treat heart arrhythmia. If Tikosyn is taken in place of Effexor, there is potential for severe injury.
The recall covers:
Effexor XR® 150 mg extended-release capsules
Venlafaxine HC1 150 mg extended-release capsules
If you have either of these products, it is suggested that you cease its use and return any remaining medication to your pharmacy. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor. Patients can also contact Stericycle at 1-888-345-0481 Monday through Friday 8am to 5pm EST, with questions regarding this recall and product reimbursement.
Benecard will be contacting members who have received one of these recall medications through Benecard Central Fill mail service pharmacy with further information.
January 14, 2014, Merck & Co issued a voluntary recall of Liptruzet because there were defects in the medications foil packaging. It is possible that the packaging defect could allow moisture and air in which may decrease the medications effectiveness.
Liptruzet is a combination drug that is used to treat LDL (bad) cholesterol in two ways. Liptruzet reduces naturally occurring cholesterol levels and works to block the body’s absorption of cholesterol.
The recall covers all 4 lots of this medication that have been produced since Liptruzet was first introduced in May 2013 and includes all dosage strengths.
Patients taking Liptruzet may continue taking the drug. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
Ondansetron Injection, USP, Recalled
October 1, 2013, Hospira, Inc. has issued a voluntary recall of Ondansetron Injection, USP. The recall was due to a vial defect where particles were found inside of the vials. The two affected lots are 29-484-DK and 29-510-DK with an expiration date of May 1, 2015.
The particles found the containers were identified as glass strands. If the particles go unnoticed, there is potential for severe injury.
Ondansetron is used to prevent vomiting and nausea during cancer treatments and after surgery.
For replacement product please call Stericycle at 1-877-497-3125 Monday through Friday, 8am to 5pm EST.
Fosinopril Sodium and Hydrochlorothiazide Tablets Recalled
October 11, 2013, Sandoz, Inc. issued a recall of Fosinopril Sodium and Hydrochlorothiazide. The single lot affected by the recall was #CU0856 with the expiration date of 04/2014. The Fosinopril Sodium and Hydrochlorothiazide recall was due to low Hydrochlorothiazide potency in the drug. There are no health risks that have been reported due to this recall.
Fosinopril Sodium and Hydrochlorothiazide is used for the treatment of high blood pressure by preventing the absorption of salt and relieving fluid retention. Fosinopril Sodium and Hydrochlorothiazide is also used to treat congestive heart failure.
If you have this product, it is suggested that you cease its use and check with the dispensing pharmacy to see if your medication came from the lot that was recalled.. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
For product reimbursement and replacement questions regarding this recall, please call Sandoz Customer Support at 1-800-525-8747.
Reminder: Too Much Acetaminophen Can Be Harmful, Always Read Medication Labels
It is important that you always review your medication labels and do not exceed the recommended dose. Acetaminophen is a safe and effective medication if used correctly. However, since acetaminophen is found in so many over-the-counter medications including fever reducers, pain relievers, and cough and cold products, accidental overdose happens all too often. Care should be used when taking drugs containing this product because taking too much acetaminophen can cause severe liver damage.
For any medications containing acetaminophen, the Food and Drug Administration (FDA) recommends a limit of 325 mg per dose. The maximum allowance per days remains at 12 doses which should not exceed 4000 mg of acetaminophen.
If you have questions regarding acetaminophen you should talk to your healthcare provider, or for more acetaminophen safety tips visit www.knowyourdose.org.