Metoclopramide, Ondansetron Injection Drug Recall [US]

US FDA RecallUS/Silver Spring: Hospira recalls one lot of Metoclopramide Injection and two lots of Ondansetron Injection due to glass particle and/or glass strand hazards. FDA: http://ht.ly/puSAa

Direct link: http://www.fda.gov/Safety/Recalls/ucm370658.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drugs are subject to this recall:

  • 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 October 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.

Both products are packaged as 25 units per carton/100 units per case in glass fliptop vials.

According to the FDA, 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.

___________________________________________________________

Recalls Direct RIN: 2013-2577
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org
E. & O. E.

☞ Want to share this recall with family, friends or work colleagues? Simply use the “Share this” options directly below.
☞ Appreciate this recall notification? Just click on the “Like” button below.

 

%d bloggers like this: