SHIRLEY, N.Y., March 29, 2011 /PRNewswire/ -- Yesterday American Regent, Inc. issued a letter regarding a product recall from February 2011. The text of the letter follows:
Dear Healthcare Professional,
Recently, American Regent, Inc. recalled Sodium Thiosulfate Injection, USP, 10%, 10mL Single Dose Vials, Lot #0056, because some of the vials of this lot contained translucent visible particles that have been identified as glass delamination. The particles detected in Lot #0056 ranged in size from < 5 microns to about 350 microns.
Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent recalled Sodium Thiosulfate Injection lot #0056 on February 2, 2011 in consideration of the potential for safety issues if this lot of product was administered to patients.
Retention samples of all other lots and sizes of this product in commercial distribution (see below for sizes and NDC #s) have been visually re-inspected and have not exhibited visible evidence of glass delamination or translucent visible particles indicative of glass delamination. Our retention inspection program requires samples be visually inspected at appropriate intervals to ensure there is no evidence of deterioration in our products. American Regent has already taken other steps, such as changing the source of glass used, to help address this problem.
As a precautionary measure, American Regent recommends that, until further notice, a filter be used for the withdrawal and administration of this product.
The following procedure should be used for the compounding and administration of Sodium Thiosulfate Injection, USP (this does not apply to the recalled Lot #0056, which should not be administered).
- Perform a visual inspection on the vial prior to withdrawal of the contents. DO NOT USE IF PARTICULATES ARE PRESENT. USE A NEW VIAL.
- Use a 5 micron filter needle to withdraw the required calculated volume of Sodium Thiosulfate Injection, USP.
- Remove the filter needle and attach a standard needle to the syringe before adding to a larger volume of IV fluid and/or prior to patient administration.
- Visually inspect the final IV admixture solution. DO NOT USE IF PARTICULATES ARE VISIBLE. USE A NEW VIAL.
- Use a 0.22 micron in-line filter when administering the final IV admixture to patients.
If particulates are observed, or if you require additional information, please call American Regent at 1-877-788-3232 then press 2 for the Professional Services Department (Monday - Friday: 9:00am-5:00pm ET) or by e-mail at inquiry@americanregent.com
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm . Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This letter is being distributed with the knowledge of the U.S. Food & Drug Administration.
We apologize for any inconvenience that you may experience and appreciate your cooperation in this matter.
Sincerely yours,
Walter A. Tozzi, R.Ph., MS, MBA
Sr. Director, Marketing & Professional Services
SodiumThiosulfate Injection, USP | Vial Sizes | NDC # | |
10% (100mg/mL) | 10mL SDV | 0517-1019-05 | |
25% (250mg/mL) | 50mL SDV | 0517-5019-01 | |
SOURCE American Regent, Inc.
