Hospira Recalls Gentamicin Sulfate Injection Due to Visible Particulate Matter
Hospira Inc. is recalling 168,300 vials of Gentamicin Sulfate Injection USP 80 mg/2 mL because visible particles were found floating in the primary container.
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 hazard involves visible particulate matter in an injectable drug without reported illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Hospira Inc. is recalling 168,300 vials of Gentamicin Sulfate Injection USP 80 mg/2 mL (40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial. The product is identified by NDC 0409-1207-13, Lot 07-067-DK, and an expiration date of 07/13. The recall was initiated because visible particles were identified floating in the primary container.
The affected product is a prescription-only medication manufactured by Hospira, Inc. in Lake Forest, IL, and distributed nationwide. It is intended for intramuscular or intravenous use. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the manufacturer for further instructions or a replacement. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- GENTAMICIN SULFATE (GENTAMICIN SULFATE)
- Brand
- GENTAMICIN SULFATE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antibiotic Injection
- Affected units
- 168,300
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 (1)
- Lot 07-067-DK Exp. 07/13
Distribution
Distributed nationwide across the United States.
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