Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0603-2021·Announced 2021-06-16

Sodium Chloride 0.9% USP 1000 mL Recall for Temperature Abuse

Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.

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 2/5 (Moderate).

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: This is an FDA Class II recall involving a pharmaceutical product. Although temperature abuse raises concerns about sterility and stability, the source text does not report any illnesses, injuries, or hospitalizations. The recall is precautionary based on a manufacturing/handling condition rather than confirmed harm.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling Sodium Chloride 0.9%, USP, 1000 mL (NDC 46163-0300-10), manufactured by Fresenius Medical Care North America in Waltham, MA. The affected lot is #20NG02095 with an expiration date of October 2021. This is a Class II recall.

The product was exposed to temperatures outside the manufacturer's specified storage limits. This temperature abuse may have compromised the product's integrity, including its sterility and chemical stability.

Approximately 48 cases were distributed nationwide within the United States. Sodium Chloride 0.9%, USP is used for medical purposes, and exposure to improper temperatures may render it unsuitable for its intended use.

Consumers and healthcare facilities should discontinue use of affected product from this lot and contact Fresenius Medical Care or their healthcare provider with questions.

The recalled product

Product: Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Drug — Injectable Solution
Hazard: temperature-abuse
compromised-sterility
Affected units: 48

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 #: 20NG02095
Exp. Date October 2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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