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The recall is a major setback in the ongoing sodium bicarbonate shortage.
Hospira Inc., a Pfizer company, announced that it is voluntarily recalling many lots of sodium bicarbonate injectables.
The recall comes in the middle of a severe nationwide sodium bicarbonate shortage. Companies are scrambling to come up with new supplies of the vital drug because of increased demand, but new product is only slowly trickling into the market.
The current recall affects 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials and five lots of Neut (Sodium Bicarbonate 4% additive solution) 5 mL vials. Hospira is also recalling five lots of Quelicent (succinylcholine chloride injection, USP) 200 mg/10 mL vials, and seven lots of potassium phosphates injection, USP, 45 m, vials, according to the FDA.
The recall is due to microbial growth detected during a manufacturing process simulation, which may mean that microorganisms are present in these products. No batch has actually been found to have microorganisms-but the possibility could exist. So far Hospira has not reported any adverse reactions.
The recall affects wholesalers and hospitals in all of the United States (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore, distributed between January and June of this year.
Drug Topicsreported on the shortage of sodium bicarbonate solution. Compounding pharmacists could help to solve the shortage, but currently face many barriers to getting the drugs into the hands of physicians and hospitals. The International Academy of Compounding Pharmacists (IACP) weighed in on the crisis, saying that compounding is a way to alleviate the strain.
“Patient harm, as a result from limited-to-no-access of a drug shortage product, can be remedied if FDA understands that access to compounded preparations goes much farther than the brick and mortar of a pharmacy,” said Baylor Rice, RPh, FIACP, President of IACP. “Prescribers, nurses, and other health-care entities require that compounded preparations need to be available for immediate use in emergency situations. The only way to meet this requirement is for the practitioner to house a small supply of the product in the practitioner’s office.”
A new bill introduced in Congress last week, HR 2871, could open up patient access to the drugs.