Baxter Recalls Pantoprazole Sodium Infusion Bags Due to Manufacturing Deviations
Baxter Healthcare is voluntarily recalling specific lots of Pantoprazole Sodium infusion bags due to Current Good Manufacturing Practice (CGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is voluntary due to CGMP deviations. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Pantoprazole Sodium in 0.9% Sodium Chloride Injection. The affected product is an 80 mg/100 mL single-dose infusion bag intended for intravenous use. The recall is limited to Lot # NC194129, which has an expiration date of 05/07/2028.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. 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 records for the specific lot number and expiration date listed above. If the product is found, it should be quarantined and not administered. Baxter Healthcare is the firm responsible for the recall and initiated the action voluntarily.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Prescription Drug
- 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 # NC194129
- Exp Date: 05/07/2028.
Distribution
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