Hospira Issues Recall of Labetalol Hydrochloride Injection, USP, to the Hospital/Institution Level – APhA submits compounding comments to FDA. – (866) 348-2889
Hospira, Inc, a Pfizer company, is recalling three lots of labetalol hydrochloride injection, USP, 100 mg/20 mL vial, and one lot of labetalol hydrochloride injection, USP, Novaplus® to the hospital/institution level due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal. To date, Hospira has not received any reports of adverse events associated with this issue for the affected lots.
Labetalol hydrochloride injection is packaged in a 20 mL multiple dose fliptop vial per carton, packaged in 50 cartons per case. For cartons, the National Drug Code (NDC) is located on the top and front label, and the lot and expiry date are located on the bottom. For individual vials, the NDC, lot, and expiry date are located on the vial label.