Hospira Recalls Epinephrine Injection Due to Potential Glass Particulates
Hospira is recalling specific lots of Epinephrine Injection USP because they may contain glass particles.
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 score of 4 (Severe), particularly when involving potential physical hazards like glass particles in injectable medications.
Plain-English summary
Hospira Inc. is recalling 361,600 one-mL ampules of Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM. The affected product is identified by NDC 0409-7241-01 and includes Lot 100953A (Exp 01OCT2013) and Lot 120803A (Exp 01DEC2013). The recall was initiated because the product may contain glass particles.
The recall is classified as FDA Class II by the U.S. Food and Drug Administration. The product was distributed nationwide. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and consumers should check their inventory for the specific lot numbers and expiration dates listed above. If these products are found, they should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
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 100953A
- Exp 01OCT2013
- Lot 120803A Exp 01DEC2013
Distribution
Distributed nationwide across the United States.
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