FDA advises health care professionals not to use any Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions. The solution is manufactured by BioDiagnostics International, Brea, California, and distributed by MedGyn Products, Inc., Addison, Illinois. BioDiagnostics notified MedGyn of the recall of all lots of Monsel’s Solution on June 11,…
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…
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…
Bayer Issues Voluntary Recall Of Alka-Seltzer Plus Products
Bayer is voluntarily recalling Alka-Seltzer Plus packages that: Were sold only in the U.S. at Walmart, CVS, Walgreens, and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers, and Smith’s Food and Drug) after February 9, 2018. Can be identified by checking the Bayer logo located on the lower left corner of…
FDA Working To Withdraw Zinbryta From US Market
On March 2, Biogen and Abbvie announced a voluntary withdrawal of Zinbryta (daclizumab), a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile. As a result, FDA is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States, and to…