Agency classClass IIOur severity:High FDA (Drugs)·D-1190-2018·Announced 2018-09-26

Baxter Recalls 5,184 Bags of 0.9% Sodium Chloride Injection Due to cGMP Deviation

Baxter Healthcare is voluntarily recalling 5,184 bags of 0.9% Sodium Chloride Injection USP 50 mL due to a cGMP deviation. The FDA classified this as a Class II recall.

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 FDA classified this as a Class II recall involving a cGMP deviation for an intravenous drug. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' warranting a score of 3.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling 5,184 bags of 0.9% Sodium Chloride Injection USP 50 mL Viaflex containers. The product is identified by NDC 0338-0049-31, Lot P380063, and an expiration date of 12/2019. The recall was initiated on September 6, 2018, and the product was distributed nationwide.

The reason for the recall is a Current Good Manufacturing Practice (cGMP) deviation. The FDA classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The recall status is currently terminated.

Healthcare providers and consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures. 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 Fluid
Hazard: cGMP-deviation
contamination
Affected units: 5,184

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 (1)

Lot: P380063 Exp. 12/2019

Distribution

Distributed nationwide across the United States.

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