Bacteriostatic Sodium Chloride Injection 0.9% from American Regent - Recall Due to Particulates
March 21, 2011
American Regent is voluntarily recalling 3 lots of bacteriostatic sodium chloride injection 0.9% in 30 mL multiple dose vials (NDC #0517-0648-25). Vials of the affected lots may contain visible particulates. Solutions containing particulates may pose a safety risk if administered to patients. The following product is are affected by this recall:
- Lot # 9330 (expiration date 5/2011)
- Lot # 9599 (expiration date 8/2011)
- Lot # 9828 (expiration date 12/2011)
Avoid administering the affected products and immediately quarantine the recalled vials for return to the manufacturer. Immediately quarantine and avoid administering the affected products. Visually assess all parenteral drug products before administration and discard if particulates and color changes are present.
Healthcare providers with questions may contact American Regent at 1-877-788-3232, weekdays from 8:30AM to 7:00PM Eastern Standard Time. American Regent will credit accounts for all returned products from the affected lots. To report adverse effects from the use of any of the recalled lots, contact American Regent at PV@luitpold.com, 1-800-734-9236 (phone), 1-610-650-0170 (fax), or 1-610-650-7781 (fax); or report adverse events to FDA’s MedWatch program.
Additional information is available at the following links:
- MedWatch Alert:
- Firm Press release:
- Photographs of vial labels:
March 21, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.