Hospira Recalling 21 Million Units of Three Injectables
Hospira is voluntarily recalling a total of over 21 million units of three injectable products through three separate recalls.
The Lake Forest, Ill., drugmaker’s biggest culprit is the nonsteroidal anti-inflammatory drug ketorolac tromethamine injection, with 20.69 million single-dose vials being recalled because the calcium salt is crystalizing. The recall involves 64 lots, 10 of which — totaling more than 3.25 million vials — carry the Novaplus label, according to an FDA enforcement report.
The recall was initiated by Hospira on June 30 and affects product in the U.S., Puerto Rico, Guam, Canada and Singapore.
The drugmaker also recalled two lots of sodium chloride injection, comprising 314,600 bags, because of sterility issues. The bags have the potential to leak near the threaded vial port, Hospira says. The firm initiated the recall on July 2 on products distributed in the U.S.
The sodium chloride comes in the midst of a nationwide saline shortage, which was further hampered last week when Baxter recalled 237,000 units of its sodium chloride product.
Hospira spokeswoman Julie Ferguson says the firm does not know how much product remains on the market.
Recalls have plagued the company in the past year, with particulate contamination forcing the recall of injectables and repeated problems with the GemStar infusion pump causing headaches on the device side of the business.
To view the enforcement reports, go to www.fdanews.com/07-24-15-HospiraSodiumChloride.pdf, www.fdanews.com/07-24-15--Ketorolac30.pdf and www.fdanews.com/07-24-15--Ketorolac60.pdf. — Kellen Owings