Recall: Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL)


Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL)

Product Detail

Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed a 01), is packaged in a 2 mL single-dose fliptop vial, manufactured Hospira Inc, Lake Forest, IL


Expiration date of October 1, 2014

Reason for Recall

The recall is based on a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution. 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.

Recalling firm:

Hospira Inc
Lake Forest

Voluntary or mandated: voluntary, firm initiated

Distribution: Nationwide