- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
Qualitest recalls pain-relief tablets due to label mix-up
A voluntary nationwide retail level recall of generic pain-relief tablets combining
A voluntary nationwide retail level recall of generic pain-relief tablets combining
butalbital, acetaminophen, and caffeine, as well as one combining hydrocodone bitartrate and acetaminophen is currently under way, according to a press release from FDA’s website on June 24.
Qualitest Pharmaceuticals initiated the recall after finding that a bottle of tablets containing butalbital, acetaminophen, and caffeine USP, 50 mg/325 mg/40 mg, 500 count was incorrectly labeled as hydrocodone bitartrate and acetaminophen Tablets, USP 7.5 mg/500 mg, 1,000 count. Though no injuries have been reported, patients who accidentally take butalbital and caffeine instead of hydrocodone may experience symptoms such as sedation, lightheadedness, dizziness, and nausea (butalbital) or tremors, irritability, and difficulty sleeping (caffeine). Patients with an allergy to butalbital could experience a hypersensitivity reaction, the press release stated.
The recall covers lots that were distributed between November 13, 2009, and April 9, 2010, to wholesale and retail pharmacies nationwide, including Puerto Rico.
The recalled product and lot numbers include:
Butalbital, Acetaminophen, and Caffeine Tablets, 500 count, contains 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. It is available as white, round-shaped tablets, debossed “2355” on 1 side, and debossed “V” on the reverse side.
NDC 0603-2544-28
Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/500 mg, 1,000 count, are supplied as white with green specks, capsule-shaped, scored tablets, debossed “3594” on one side and debossed “V” on the reverse side.
NDC 0603-3882-32,
Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
Customers who may have received affected product can contact Qualitest at (800) 444-4011 to arrange for its return. Adverse reactions or quality problems should be reported to the manufacturer or to FDA’s MedWatch Adverse Event Reporting program [https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm].
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
