Drugs

FDA updates on Pfizer drug shortages

UPDATE [6/23/17] Additional emergency syringe products with extended use dates

Based on stability data provided by Pfizer and reviewed by the FDA, the following additional emergency syringe products have extended use dates by lot number, click here for details:

  • Atropine Sulfate Injection, USP 0.1 mg/mL; 10 mL Ansyr Plastic syringe (NDC 0409-1630-10)
  • Dextrose injection 50% (0.5 g/mL); 25 g/50 mL Ansyr Plastic Syringe (NDC 0409-7517-16)
  • Sodium Bicarbonate Injection, USP 8.4% (1 mEq/mL); 50 mEq/50 mL Abboject Glass Syringe (18 G x 1 ½" needle (NDC 0409-6637-34)

UPDATE [6/16/17] FDA announces Hospira’s voluntary recall of drugs in shortage due to sterility concerns

FDA is alerting health care professionals that Hospira, Inc., a Pfizer company, is voluntarily recalling several drug products currently in shortage:

Hospira is also recalling the following drug product that is not currently in shortage:

  • Quelicin (succinylcholine chloride injection) 200 mg/10 mL vials, 5 lots

These recalls are due to a potential lack of sterility assurance. See the recall notice for a list of the affected lot numbers. Anyone with an existing inventory of the recalled lots should immediately quarantine the products and not administer them to patients.

 

FDA 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.

 

FDA will post information on the drug shortages webpage to inform health care professionals of alternative sources of products to help relieve the shortages.

Additionally, Alvogen Inc. is voluntarily recalling 7 lots of clindamycin injection 300 mg/2 mL; 600 mg/4 mL; 900 mg/6 mL ADD-vantage, distributed in 25-count packs, also manufactured by Hospira, due to a potential lack of sterility assurance. This drug product is not in shortage, and this recall should not result in a shortage. These lots are:

  • 68-104-EV
  • 68-105-EV
  • 68-106-EV
  • 73-154-EV
  • 73-155-EV
  • 73-156-EV
  • 73-157-EV

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of medical products to FDA’s MedWatch Adverse Event Reporting program:


[6/15/17] 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.

 


 

Page Last Updated: 06/23/2017
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