OCT 02, 2013
Hospira, Inc. announced a voluntary nationwide recall of certain lots of metoclopramide and ondansetron due to a confirmed defect of glass strands on the inside of vial walls. There is potential for the glass particulates to dislodge into the solution. No adverse events have been reported to date.
Affected lots include:
- Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed by a 01), is packaged in a 2 mL single-dose fliptop vial, with an expiration date of Oct. 1, 2014.
- Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK (the lot numbers may be followed by a 01) are packaged in a 2 mL single-dose fliptop vial, with an expiration date of May 1, 2015.
The affected lots were distributed nationwide between June 2013 and September 2013 to wholesalers/distributors, hospitals and pharmacies. Both products are packaged as 25 units per carton/100 units per case in glass fliptop vials.
Hospira recommends that those with existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-497-3125 between the hours of 8 a.m. to 5 p.m. (EST), Monday through Friday, to arrange for return of the product. Replacement product from other lots is available.
Also, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online at www.fda.gov/MedWatch/report.htm1;
- 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.