A voluntary nationwide recall has been initiated for one lot of Metoclopramide Injection 10mg/2mL (5mg/mL) and two lots of Ondansetron Injection 4mg/2mL (2mg/mL), both manufactured by Hospira.
This action is due to a confirmed vial defect where glass particulate matter was identified as being affixed to the inside of the vial walls. The products included in this recall are:
- Metoclopramide Injection 10mg/2mL (5mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed by a 01); packaged in a 2mL single-dose fliptop vial, expiration date: 10/1/14
- Ondansetron Injection 4mg/2mL (2mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK (the lot numbers may be followed by a 01); packaged in a 2mL single-dose fliptop vial, expiration date: 5/1/15
Both products are packaged as 25 units per carton/100 units per case in glass fliptop vials. The affected lots were distributed nationwide between June 2013 and September 2013.
The administration of an injectable with the presence of foreign particulates may potentially result in local inflammation, thrombophlebitis, and/or low-level allergic response.
Signs and symptoms could include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea and vomiting.
Additionally, the particulate contaminants could potentially act as an emboli and impede blood flow, causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, infants, children and the elderly, as well as patients with micro or macrovascular disease, such as cardiac and renal disease, who may be more at risk since their vasculature, and end organs, are already compromised.
Metoclopramide Injection is indicated for the prevention of nausea and vomiting (N/V) associated with emetogenic cancer chemotherapy and also for postoperative N/V. It is also used to facilitate small bowel intubation and to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination.
Ondansetron Injection is indicated for the prevention of N/V associated with initial and repeat courses of emetogenic cancer chemotherapy and also for postoperative N/V.
For more information visit FDA.gov.