Hospira Recalling Selected Lots of IV Reglan and Zofran
Glass strand particulates caused by glass supplier defect are to blame.
Published: October 2, 2013
Hospira has initiated a voluntary nationwide recall of 1 lot of Metoclopramide Injection (Reglan), USP, 10 mg/2 mL (5 mg/mL) and 2 lots of Ondansetron Injection (Zofran), USP, 4 mg/2 mL, (2 mg/mL), says the FDA. Reglan and Zofran prevent or treat nausea after surgery.
The recall is due to a confirmed vial defect where strands of glass were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution, says the FDA. To date, Hospira has not received reports of any adverse events associated with this issue for these lots.
Here's how to tell if you have any affected lots.
- Metoclopramide. 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 flip-top vial, with an expiration date of October 1, 2014.
- Ondansetron. 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 flip-top vial, with an expiration date of May 1, 2015.
Both products are packaged as 25 units per carton/100 units per case in glass flip-top vials. The affected lots were distributed nationwide between June 2013 and September 2013 to wholesalers/distributors, hospitals and pharmacies.
The administration of an injectable with the presence of foreign particulates may potentially result in local inflammation, thrombophlebitis and/or low-level allergic response. 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.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately and call Stericycle at (877) 497-3125 during business hours to arrange for the return of the product. Replacement product from other lots is available.
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