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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Injection
- Hazard
- 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.
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