Prescription opioid cough and cold medicines: Drug Safety Communication — FDA requires labeling changes. AUDIENCE: Family Practice, Pediatrics ISSUE: FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh…
Blood Thinner Tablets Are Recalled Due To Mislabeling
Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall — Product Mislabeling. AUDIENCE: Pharmacy, Patient ISSUE: 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…
Glass Particles In Vial Prompt Infection Treatment Recall
Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall — Presence of glass particles in vial. AUDIENCE: Pharmacy, Risk Manager ISSUE: AuroMedics Pharma is voluntarily recalling one lot of Ampicillin and Sulbactam for Injection USP, 1.5 g in a Single-Dose vial (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g…
Recall: Improper Seal Can Allow Blood To Leak Through Sheath Hub
Lack Of Sterility Assurance Leads To Recall Of Numerous PharMEDium Lots
Compounded sterile products by PharMEDium Services: Recall — Lack of sterility assurance. AUDIENCE: Risk Manager, Pharmacy ISSUE: PharMEDium Services is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in…
Linezolid Injection Bags Recalled After Presence Of Mold Found
Linezolid Injection 600mg/300mL flexible bags: Recall — Due to presence of white particle matter that has been identified as mold. AUDIENCE: Risk Manager, Pharmacy, Nurse ISSUE: AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was…
Glass Particle Presence Prompts Recall Of Gastroesophageal Reflux Med
Pantoprazole Sodium for Injection 40 Mg per vial: Recall — Presence of glass particles. AUDIENCE: Pharmacy, Gastroenterology ISSUE: 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…
FDA Removes Boxed Warning About Asthma-Related Death
Long-acting beta agonists (LABAs) and inhaled corticosteroids (ICS): Drug Safety Communication — Boxed Warning about asthma-related death removed. AUDIENCE: Pharmacy, Pulmonology, Internal Medicine, Family Practice ISSUE: FDA’s most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review…
FDA Issues Warning Over Gadolinium-Based Contrast Agents
Gadolinium-based contrast agents (GBCAs): Drug Safety Communication — Retained in body; new class warnings. AUDIENCE: Radiology, Health Care Professional, Patient ISSUE: FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to…
FDA Cautions About Fading Label On CSL Behring Albumin Product
Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory — Fading Print On Label. AUDIENCE: Risk Manager, Critical Care Medicine, Emergency Medicine ISSUE: During routine inspection of retained AlbuRx 25% samples CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the…