Hospira Recalls Levophed Injection Due to Foreign Stopper Observation
Hospira is recalling specific lots of Levophed (norepinephrine bitartrate) injection after a foreign stopper was observed during packaging.
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a GMP deviation (foreign stopper) without reported injuries.
Plain-English summary
Hospira Inc., a Pfizer company, is recalling specific lots of Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL. The recall was initiated due to a Good Manufacturing Practice (GMP) deviation where a foreign stopper was observed during the packaging of a lot of product.
The affected product is distributed nationwide in the United States, as well as in Canada and Singapore. The specific lot codes involved are 720503A and 720603A (Canada only). The recall covers 43,200 vials for lot 720503A and 400 vials for lot 720603A.
Healthcare providers and patients should check their inventory for these specific lot numbers. If the product is found, it should be quarantined and not administered. Patients who have received this product should contact their healthcare provider for guidance.
The recalled product
- Product
- LEVOPHED (NOREPINEPHRINE BITARTRATE)
- Brand
- LEVOPHED
- Manufacturer
- Hospira Inc., A Pfizer Company
- Category
- Drug — Prescription Injection
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 (2)
- 720503A
- 720603A (Canada only)
Distribution
Distributed nationwide across the United States.
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