Baxter Recalls 0.9% Sodium Chloride Injection Due to CGMP Deviations
Baxter Healthcare is recalling 33,600 bags of 0.9% Sodium Chloride Injection USP due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed only in Texas and Mississippi.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses or injuries, and the hazard is related to manufacturing deviations rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Baxter Healthcare Corporation has voluntarily recalled 33,600 bags of 0.9% Sodium Chloride Injection USP, 100 mL bags (NDC 0338-0049-18). The recall was initiated on August 21, 2018, and was classified as Class II by the FDA. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations.
The affected product is identified by Lot # P380287 with an expiration date of 12/2019. The recall status is currently terminated, with a termination date of October 30, 2019. The product was distributed only in the states of Texas and Mississippi.
Consumers and healthcare providers who have this specific lot of the product should stop using it and contact their healthcare provider or the manufacturer for instructions on how to return or dispose of the product. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — IV Fluids
- Hazard
- Affected units
- 33,600
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 #: P380287
- Exp. date 12/2019
Distribution
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