Hospira Recalls Sodium Chloride Injection Vials Due to Particulate Matter
Hospira is recalling 268,700 vials of Sodium Chloride Injection, USP, 0.9% due to a confirmed report of visible particulate matter embedded in the plastic vial.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential adverse health consequences from particulate matter in injectable drugs.
Plain-English summary
Hospira, Inc. is recalling 268,700 vials of Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial. The recall was initiated following a confirmed customer report of visible particulate matter in the form of an orange or rust-colored ring embedded between the plastic layers of the vial.
The affected product is identified by Lot # 15-058-DK* (where the asterisk may be followed by 01) and has an expiration date of 1MAR2014. The product was distributed nationwide and to Guam. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials and contact Hospira, Inc. for further instructions or a replacement. The product is a prescription-only medication intended for intramuscular, intravenous, or subcutaneous administration.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 268,700
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 (3)
- Lot #: 15-058-DK*
- Exp 1MAR2014
- note the * may be followed by 01
Distribution
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