Infusion Options Inc. Issues Voluntary Nationwide Recall of All Lots of All Sterile Products Due to Lack of Assurance of Sterility
- Company Announcement Date:
- June 18, 2019
- FDA Publish Date:
- June 20, 2019
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionLack of Sterility Assurance
- Company Name:
- Infusion Options Inc.
- Brand Name:
Brand Name(s)Infusion Options Inc.
- Product Description:
Product DescriptionAll sterile products within expiry
Infusion Options Inc. is voluntarily recalling all lots of all sterile products within expiry to the hospital level. These products are being recalled due to a lack of assurance of sterility.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Infusion Options Inc. has not received any reports of adverse events related to this recall.
Products were distributed in Brooklyn, N.Y. to a hospital. Infusion Options Inc. is notifying its customers by letter and email and is arranging for return of all recalled products.
Consumers that have products from Infusion Options Inc within expiry should stop using and return to Infusion Options Inc. for destruction.
Consumers with questions regarding this recall can contact Infusion Options Inc. at 718-283-7233, Monday-Friday 9am-5pm, EST or at email@example.com.. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Nabil Gergi