The Recall Desk
SevereFDA (Drugs)·D-1057-2014·Announced 2014-02-12

Baxter Recalls Nitroglycerin Injection Due to Particulate Matter

Baxter Healthcare is recalling 49,932 vials of Nitroglycerin in Dextrose Injection because particulate matter was found in one vial.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

Baxter Healthcare Corp. is recalling 49,932 glass containers of Nitroglycerin in Dextrose Injection (200 mcg/mL), 250 mL, NDC 0338-1049-02. The recall was initiated due to the presence of particulate matter in one vial, which was identified as silicone rubber and EPDM rubber from the vial stopper.

The affected product is distributed nationwide, as well as in Saudi Arabia and Colombia. The specific lot code is G105197 with an expiration date of 02/14.

Healthcare providers and consumers should discontinue use of the recalled product and contact Baxter Healthcare for further instructions or a replacement.

The recalled product

Product
NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN)
Brand
NITROGLYCERIN IN DEXTROSE
Affected units
49,932

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • G105197
  • Exp. 02/14

Distribution

Distributed nationwide across the United States.