- Pfizer Inc.'s Hospira unit issued a voluntary recall of three lots of labetalol hydrochloride injection 100 mg/20 mL vials and one lot of labetalol hydrochloride injection Novaplus.
- Hospira made the recall after the "discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal."
- The affected lots were distributed to wholesalers, hospitals and retailers in the U.S. and Puerto Rico from April to August 2017.
The recall statement from Hospira noted that the cracks in the glass vials could result in sterility issues for the blood pressure medication.
Non-sterile medicines have been known to cause adverse events, including fever, chills, sepsis and infections. Hospira noted there have been no safety issues reported to date for these lots.
The recall is just the latest manufacturing snafu to come out of Pfizer's McPherson, Kansas fill-and-finish site, which In-PharmaTechnologist first reported produced the affected lots. Pfizer acquired the plant in its $17 billion acquisition of Hospira in 2015.
Yet, the facility has had a number of issues. It received a warning letter in February 2017 from the Food and Drug Administration that led to a delay in the approval of Novartis AG and Momenta Pharmaceuticals Inc.'s copycat version of Teva Pharmaceutical Industries Ltd.'s multiple sclerosis drug Copaxone (glatiramer acetate). The warnings letter came after FDA inspectors observed tiny particulates of cardboard in the drug product being produced.
The regulatory agency later reclassified the McPherson plant, upgrading it to Voluntary Action Indicated. But it also issued a Form 483 with nearly a dozen observations to the facility.
One observation noted employees at the plant were not sufficiently trained to perform the functions they were doing, while another said that cleaning procedures put in place to prevent microbiological contamination were not being followed. The observations also said that drug products were not being stored at the appropriate temperature, among other violations.