Baxter Recalls Dexmedetomidine Hydrochloride Injection Due to Manufacturing Deviations
Baxter Healthcare is voluntarily recalling specific lots of Dexmedetomidine Hydrochloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.
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 recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Per the rubric, FDA Class II recalls are assigned a severity score of 4.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection. The product is a prescription-only intravenous medication packaged in 100 mL single-dose containers. The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations.
The affected lots are NC188654 (expiration date 08/31/2027), NC188821 (expiration date 09/30/2027), and NC193658 and NC193702 (expiration date 01/31/2028). The product was distributed nationwide in the United States, as well as in Puerto Rico and Chile.
Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If the product is found, it should be quarantined and not administered. The recall is ongoing, and Baxter Healthcare has notified customers via letter.
The recalled product
- Product
- DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE)
- Brand
- DEXMEDETOMIDINE HYDROCHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Prescription Injection
- Hazard
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 (7)
- Lot # NC188654
- Exp Date: 08/31/2027
- Lot # NC188821
- Exp Date: 09/30/2027
- Lot # NC193658
- NC193702
- Exp Date: 01/31/2028.
Distribution
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