Baxter Recalls Daptomycin Injection Due to Manufacturing Deviations
Baxter Healthcare is voluntarily recalling Daptomycin in Sodium Chloride 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 source text explicitly identifies the recall as FDA Class II. Per the severity rubric, FDA Class II recalls are classified as Severe (Score 4), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling Daptomycin in 0.9% Sodium Chloride Injection, 500 mg per 50 mL, NDC 0338-0714-24. The recall is initiated due to Current Good Manufacturing Practice (CGMP) deviations.
The affected product is identified by Lot # NC188692 with an expiration date of 11/22/2027. The product was distributed nationwide in the United States, as well as in Puerto Rico and Chile.
This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The recall status is ongoing.
The recalled product
- Product
- DAPTOMYCIN IN SODIUM CHLORIDE (DAPTOMYCIN IN SODIUM CHLORIDE)
- Brand
- DAPTOMYCIN IN SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Antibiotic 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 (2)
- Lot # NC188692
- Exp Date: 11/22/2027.
Distribution
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