FDA announces Hospira’s voluntary recall of drugs in shortage due to sterility concerns - Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

FDA is alerting health care professionals that Hospira, Inc., a Pfizer company, is voluntarily recalling several drug products currently in shortage:

• 8.4% sodium bicarbonate injection 50 mL vials, 42 lots distributed in the United States and 2 lots outside of the United States
• Neut (sodium bicarbonate 4% additive solution) 5mL vials, 5 lots
• Potassium phosphates injection 45 mM vials, 7 lots

Hospira is also recalling the following drug product that is not currently in shortage:

• Quelicin (succinylcholine chloride injection) 200 mg/10 mL vials, 5 lots

These recalls are due to a potential lack of sterility assurance. See the recall notice for a list of the affected lot numbers. Anyone with an existing inventory of the recalled lots should immediately quarantine the products and not administer them to patients.

FDA is concerned about how this recall will affect ongoing critical shortages and is working closely with Pfizer to resolve them by addressing the underlying causes. The recall may impact hospitals that still have supplies of the specific lot numbers.

FDA will post information on the drug shortages webpage to inform health care professionals of alternative sources of products to help relieve the shortages.

Additionally, Alvogen Inc. is voluntarily recalling 7 lots of clindamycin injection 300 mg/2 mL; 600 mg/4 mL; 900 mg/6 mL ADD-vantage, distributed in 25-count packs, also manufactured by Hospira, due to a potential lack of sterility assurance. This drug product is not in shortage, and this recall should not result in a shortage. These lots are:

68-104-EV
68-105-EV
68-106-EV
73-154-EV
73-155-EV
73-156-EV
73-157-EV

For more information, please visit: Hospira Recall