50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02

Recall Insight

This FDA Drug action (record #D-1057-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on November 18, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Deerfield, IL. Federal records indicate 49,932 glass containers units are affected.

The documented reason for this recall is: Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. Distribution data in the federal record shows the product reached: Nationwide, Saudi Arabia and Colombia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.