Production of Sodium Chloride IV Bags continues to struggle

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Baxter Healthcare, one of the top three Intravenous (IV) manufacturers in the United States, continues to struggle to produce IV bags of Sodium Chloride solution as they have just recalled nearly 140,000 bags. The FDA issued another Inspectional Observation Form 483, citing mold on the inside of the overpouch and the failure of quality controls to catch this issue. This is currently Baxter's ninth recall in less than two years.

This news comes during an ongoing shortage of IV sodium chloride bags as two of the top three manufacturers have been unable to continuously supply product into the market to meet demand. The 1,000mL bags are most affected by the shortage. However, this will likely have a negative impact to all general purpose (D5W, NaCl and Sterile Water) 500mL bags as hospitals move to substitute the 1,000mL.

The FDA has recently stepped in to assist in the shortage by approving production by FDA-approved foreign manufacturers to relieve hospitals and clinics affected by the shortage. However, it is our view that this does not seem to help relieve the shortage of IV solutions for wholesalers and independent physicians.

McGuff does not see the IV solution shortage becoming worse, but it appears the shortage will continue longer than expected.