Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial recall — FDA D-0576-2018
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Overview of recall records associated with Hospira Inc., A Pfizer Company, including dates, categories and classifications where available.
Classification mix: Class II: 5, Class I: 2, Class III: 1.
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots…
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the…
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the…
Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million…
This page summarizes recall records in which the official source identifies Hospira Inc., A Pfizer Company as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.