FDA updates on Pfizer drug shortages — Drug Information Update
The U.S. Food and Drug Administration is aware of the ongoing shortage situation affecting several injectable drugs, manufactured by Hospira, a Pfizer company, including sodium bicarbonate injection (vials and syringes), dextrose 50% injection (vials and syringes), as well as emergency syringes of other drugs, including epinephrine, calcium chloride, and atropine sulfate. Pfizer has reported this shortage is caused by manufacturing, distribution and third party delays.
We are working closely with Pfizer to resolve these critical shortages by addressing the underlying causes. The agency is working to relieve these shortages through a variety of measures, including finding alternative manufacturers of these drug products. FDA continues to explore all available options, which may include expediting review of applications or other submissions, or considering temporary regulatory flexibility for alternative sources.
In addition, certain lots of emergency syringes have had their use dates extended based on stability data provided by Pfizer and reviewed by FDA, so that healthcare professionals can continue to use these specific lots during the shortage. The information about the specific lots with extended use dates is found in these tables.
- 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)
FDA is not requiring or recommending that the identified lots in the referenced tables be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects that the lots in the referenced tables will be replaced and properly disposed of as soon as possible.
We will update the public as the situation changes. Continue to visit the drug shortages webpage for more information on approved sources of these drug products. For additional information, health care professionals can also contact Pfizer directly.
For more information visit: Pfizer drug shortages.
(Source: U.S. Food and Drug Administration)
