Hikma Recalls Sodium Chloride Injection Vials Due to pH Failures
Hikma Pharmaceuticals is recalling specific lots of Sodium Chloride Injection USP 0.9% 2 mL vials because they failed pH specifications.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a quality control failure (pH) without reported illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling approximately 2,100,646 vials of Sodium Chloride Injection, USP, 0.9%, 2 mL Single Dose Vials. The recall was initiated because out-of-specification pH test results were found in the product. The affected product is a sterile diluent intended for intramuscular, intravenous, or subcutaneous use.
The recall covers specific vial lots with expiration dates ranging from July 2021 to January 2023, as well as a specific carton lot expiring in June 2021. The product was distributed nationwide in the United States. The vials are manufactured by West-ward in Eatontown, NJ, and are sold under NDC codes 0641-0497-17 and 0641-0497-25.
Healthcare providers and patients should check their inventory and medication records for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be stopped and returned to the pharmacy or supplier. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 2,100,646
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 (9)
- a) Vial Lot #s: 078338 Exp. 7/2021
- Lot 088391
- Exp. 08/2021
- 098340
- Exp. 09/2021
- 108325 Exp. 10/2021
- 010018 Exp. 1/2023
- b) Carton Lot #: 068322
- Exp. 06/2021.
Distribution
Distributed nationwide across the United States.
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