Recall notice affects Sodium chloride vials
Published on: Wednesday, December 12, 2018
A manufacturer of retail drugs has issued a voluntary recall of a product used in recovery and preparation of donor lungs.
An incorrect statement on the product insert indicates that the packaging stoppers do not contain natural rubber latex. An investigation has revealed that one lot of Sodium Chloride Injection, USP 0.9%, 10 ml fill in a 10mL vial has stoppers containing natural rubber latex.
The lot number is 6015922 for this product, which has an HSI Code of 104-7098 and an NDC Code of 63323-186-10.
The manufacturer, Fresenius Kabi USA, has not received any reports of adverse events related to this recall. While reactions to latex due to latex exposure from a latex-containing rubber stoppers vial are rare, if exposed a reaction in susceptible individuals and for those with severe allergies could potentially be severe.
Please examine your inventory to verify whether you have any of the specified lot on hand. If you do, immediately cease distribution/use of this product and remove it from your shelves.
Contact your distributor regarding returning this product.
For full details on this recall, please visit the Nov. 20, 2018 U.S Food and Drug Administration release here.