Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
Hospira is recalling 71,550 syringes of Infant 25% Dextrose Injection because human hair was found in an internal sample. The product was distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Hospira Inc. is recalling 71,550 syringes of Infant 25% Dextrose Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe. The recall was initiated because human hair was found within an internal sample syringe. The affected product is identified by NDC 0409-1775-10, Lot 58382EV (which may be followed by 01 or 02), and an expiration date of 1OCT 2017.
The recalled product was distributed nationwide in the USA and in Puerto Rico. This is a prescription-only medication intended for intravenous use. The agency has classified this recall as Class I.
Healthcare providers and patients should stop using the affected syringes and contact Hospira Inc. for further instructions or to arrange for a return or replacement of the product.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 71,550
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 58382EV*
- Exp 1OCT 2017
- *lot may be followed by 01 or 02
Distribution
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