Brief

Hospira recalls add to drug shortages

Dive Brief:

  • Hospira is voluntarily withdrawing a handful of drugs already in shortage based on a potential lack of sterility assurance, according to a Food and Drug Administration alert.
  • The drugs affected are vials of sodium bicarbonate injection, with 42 lots distributed within the U.S. and two outside; five lots of vials of Neut (a sodium bicarbonate additive solution); seven lots of potassium phosphates injection vials; and five lots of Quelicin, which is not currently in shortage.
  • Another seven lots of clindamycin injection, which Hospira manufactures for Alvogen, Inc., are also being voluntarily withdrawn due to potential lack of sterility assurance. 

Dive Insight:

Drug shortages, caused by manufacturing, distribution and third party delays, have hampered Hospira.

The drugs currently in shortage include sodium bicarbonate injection, dextrose injection, and emergency syringes of other drugs, which include epinephrine, calcium chloride and atropine sulfate. To address some of the shortage issues, the FDA has approved the extension of the use dates on specific lots of atropine, dextrose and epinephrine, with the provision that these would be replaced and disposed if a replacement product becomes available.

Some of these shortages have been as a result of the legacy manufacturing issues inherited in Pfizer's 2015 acquisition of Hospira. The company has stated it is making progress in resolving some of these known problems, but new problems, such as the lack of sterility assurance, the discovery of human hair in a single syringe in April and the faulty practices at its plant in McPherson, Kansas seem to indicate uneven improvement. 

Pfizer attributes the most recent shortages as caused by manufacturing, distribution and third party delays. 

When manufacturers run short of basic requirements, such as with sodium bicarbonate, the supply chain can become stressed — potentially putting patients at risk.

The FDA said it is concerned about how the recall may affect the ongoing "critical shortages" and noted the recalls could impact hospitals which have supplies of the specific lot numbers. 

Solutions to the shortages could involve finding alternative manufacturers, expediting review of applications or temporarily making regulations governing alternative sources more flexible, the regulator said. 

Recommended Reading:

  • Food and Drug Administration Alertoffsite link

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Filed Under: Regulatory / Compliance Manufacturing