Hydromorphone HCL Injection USP by Hospira: Recall—Potential For Empty Or Cracked Glass Vials. AUDIENCE: Pharmacy, Risk Manager ISSUE: Hospira is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to…
Serious Deficiencies In Cantrell’s Compounding Operations Prompts FDA Recall
Compounded Drug Products from Cantrell Drug Company: FDA Warning – Serious Deficiencies in Quality and Sterility Assurance. AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: FDA is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile…
Patients With Heart Disease Warned About Antibiotic Danger
Clarithromycin (Biaxin): Drug Safety Communication—Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease. AUDIENCE: Health Professional, Internal Medicine, Cardiology, Patient ISSUE: FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years…
Product Mix-Up Leads To Recall Of Shingles, Herpes, And Chickenpox Med
Acyclovir 400mg Tablets by Apace Packaging: Recall — Product Mix-Up. AUDIENCE: Pharmacy, Patient ISSUE: Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards…
Gericare Eye Wash Recalled Over Potential Product Contamination
Gericare Eye Wash by Kareway Products: Recall—Potential Product Contamination. AUDIENCE: Consumer, Pharmacy, Risk Manager ISSUE: 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. Use…
FDA Warns That Liver Disease Med Has Been Incorrectly Dosed Daily Instead Of Weekly
Ocaliva (obeticholic acid): Drug Safety Communication—Boxed Warning Added To Highlight Correct Dosing. AUDIENCE: Pharmacy, Hepatology, Gastroenterology ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of…
Pain Relief Drug Found In Laxative Bottle Leads To Nationwide Recall
Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall – Mislabeling. AUDIENCE: Consumer, Pharmacy, Health Professional ISSUE: 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…
Levofloxacin Lot Voluntarily Recalled By AuroMedics Over Possible Mold Presence
AuroMedics Pharma LLC issues voluntary nationwide recall of Levofloxacin in 5% Dextrose 250mg/50mL. AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a single-use flexible container NDC 55150-243-46, Lot CLF160003, expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter…
Second Lot Of Baxter’s Nexterone Recalled From Market
Baxter expands voluntary nationwide recall to include second lot of Nexterone Injection due to presence of particulate matter. 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 it is expanding the recall to include a second lot (NC109123)…
FDA Warns That Injectable Emulsion May Cause Serious Hypersensitivity Reactions
Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter — Anaphylaxis and Other Serious Hypersensitivity Reactions. AUDIENCE: Pharmacy, Oncology, Nursing ISSUE: Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions…