Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in…
Pharmaceutical Recalls Down, Medical Device Recalls Up In 2Q
In the second quarter of 2018, pharmaceutical recalls dropped 27 percent to 77, which is lower than six of the last eight quarters, while recalled units dropped 95 percent to nearly 15.9 million, but in line with the recent average quarter (2013-2016), according to the latest U.S. Recall Index released August 8 by Stericycle Expert Solutions. The Recall Index covers recalls…
AuroMedics Pharma Issues Voluntary Recall Of Piperacillin And Tazobactam
AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial…
Prinston Pharmaceutical Issues Voluntary Recall Of Valsartan
The FDA is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being…
Hospira Issues Voluntary Nationwide Recall
Hospira, a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger. In the event that impacted product is administered…
EMA Review Of Zinbryta: Risks Outweigh Benefits
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs. Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict…
AuroMedics Pharma Recalls Two Injections
AuroMedics Pharma is voluntarily recalling Ampicillin and Sulbactam for injection and Piperacillin and Tazobactam for injection. Ampicillin and Sulbactam for Injection AuroMedics Pharma announced a recall of two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of…
Pharmaceutical And Medical Device Industries See Huge Jump In Recalls
A significant spike in product recalls rocked the healthcare industry in the first quarter of 2018 as both pharmaceutical and medical device companies experienced an unusually high number of problems, according to the latest U.S. Recall Index released May 8 by Stericycle Expert Solutions. The Recall Index covers recalls in the pharmaceutical, medical device, and other…
FDA Alerts Healthcare Professionals To Voluntary Recall Of Sterile Products
The FDA is alerting healthcare professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds LLC, of Biloxi, Mississippi, due to visible particles in some of the drug vials for injection. Injection of a drug product containing particulate matter may result in serious and potentially life threatening adverse events,…
Premier Pharmacy Labs Issues Voluntary Recall Of Specific Sterile Injectable Products
Premier Pharmacy Labs is voluntarily recalling the following products due to a potential lack of sterility assurance: Morphine Sulfate (Single Dose Syringe) 2mg/mL Preservative Free Injection Morphine Sulfate (Single Dose Syringe) 4mg/mL Preservative Free Injection Hydromorphone HCL (Single Dose Syringe) 1mg/mL Preservative Free Injection Neostigmine Methylsulfate (Single Dose Syringe) 1mg/mL Injection Microbial contamination was detected…