Hospira Recalls Naloxone Hydrochloride Injection Due to Particulate Matter
Hospira is recalling Naloxone Hydrochloride Injection cartridges due to the presence of particulate matter on the syringe plunger.
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 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Hospira Inc. is recalling Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringes. The recall affects 164,860 syringes distributed nationwide in the U.S., Puerto Rico, and Guam.
The recall was initiated due to the presence of particulate matter and the potential for particulate matter on the syringe plunger. The affected products are identified by lot numbers 72680LL (Exp. 1DEC2018) and 76510LL (Exp. 1APR2019).
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE)
- Brand
- NALOXONE HYDROCHLORIDE
- Manufacturer
- HOSPIRA INC, LAKE FOREST
- Category
- Drug — Injection
- Hazard
- Affected units
- 164,860
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 (4)
- 72680LL
- Exp. 1DEC2018 (NDC 0409-1782-03)
- 76510LL
- Exp. 1APR2019 (NDC 0409-1782-69)
Distribution
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