Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0169-2021·Announced 2020-12-23

Hikma Recalls Sodium Chloride Injection Vials Due to pH Failures

Hikma Pharmaceuticals is recalling 1.3 million vials of Sodium Chloride Injection USP 0.9% because pH test results were out of specification.

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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Hikma Pharmaceuticals USA Inc. is recalling 1,324,072 vials of Sodium Chloride Injection, USP, 0.9%, 2mL Single Dose Vials. The recall was initiated because out-of-specification pH test results were found in the product. The affected vials are distributed nationwide in the USA.

The specific lots subject to this recall are 048315 (EXP 4/2021), 068320 (EXP 6/2021), 128302 (EXP 12/2021), and 099349 (EXP 9/2022). The product is a prescription-only medication manufactured by West-ward in Eatontown, NJ, and is intended for intramuscular, intravenous, or subcutaneous use.

Healthcare providers and patients should check their inventory and records for these specific lot numbers. 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 consumer action is required for the general public as this is a prescription product.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Hikma Pharmaceuticals USA Inc.
Category: Drug — Injection
Hazard: ph-failure
Affected units: 1,324,072

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 (4)

Lot#: 048315 EXP 4/2021
068320 EXP 6/2021
128302 EXP 12/2021
099349 EXP 9/2022.

Distribution

Distributed nationwide across the United States.

Same brand · SODIUM CHLORIDE

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