Over concerns of sterility, Hospira Inc., a Pfizer company, has voluntarily recalled three injectable products, as of June 15, 2017.
Over concerns of sterility, Hospira Inc., a Pfizer company, has voluntarily recalled three injectable products, as of June 15, 2017. The products are frequently used by hospitals and were already in short supply due to “manufacturing, distribution, and third-party delays.” The company is working closely with the FDA to address the manufacturing issues that lead to the sterility problems.
The recalled products are:
- “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 mmol vials, 7 lots”
The FDA said that it “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.” The FDA’s efforts include sourcing other manufacturers of these products, possibly expediting reviews of alternative products, and “considering temporary regulatory flexibility for alternative sources.”
The recall includes two other products, though these are not in short supply. The same sterility concerns apply, however. The two additional products are:
- Quelicin (succinylcholine chloride injection) 200mg/10mL
- Clindamycin, 300mg/2mL
NOTE: Clindamycin is made by Hospira, but distributed by Alvogen.
The FDA asks that any healthcare provider/facility in possession of the recalled products immediately quarantine them and, above all, not use them in treating patients.
As information on alternative sources of the recalled products becomes available, the Agency will update its drug shortages webpage.
In a further effort to address the shortages, now made worse by the recall, the FDA extended the use dates of the following injectable products. Lot number information regarding this extension is available here.
Label updates reflecting the new use dates is not being required or even recommended by the Agency. It advised that these products should be replaced and properly disposed of as soon as replacement products are available.
Extended Use Date Products
- “Atropine Sulfate Injection, USP 0.1 mg/mL; 5 mL ABBOJECT syringe (NDC 0409-4910-34)
- Atropine Sulfate Injection, USP 0.1 mg/mL; 10 mL ABBOJECT syringe (NDC 0409-4911-34)
- Dextrose 50% Injection, USP, 50 mL ABBOJECT Syringe (NDC 0409-4902-34)
- Epinephrine Injection, USP 0.1 mg/mL; 10 mL ABBOJECT syringe (NDC 0409-4921-34)”
In the meantime, the FDA asks that patients and healthcare providers report any quality issues or adverse events experienced in conjunction with the use of the recalled products. Such reports can be made via the FDA’s MedWatch Adverse Event Reporting program:
- “Complete and submit the report online at fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.”
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